inforMED
MalfunctionDQO

Mariner

Received Jul 28, 2026 · Event occurred Jul 21, 2026

Report 50052622 · MDR key 50052622

Device

Generic name

Catheter, Intravascular, Diagnostic

Model number

11732702

Catalog number

11732702

Lot number

A4225077

Product problems

  • Failure to Advance
  • Detachment of Device or Device Component
  • Physical Resistance/Sticking

Patient

Male

  • Device Embedded In Tissue or Plaque
  • Insufficient Information

Narrative

Description of Event or Problem

"[redacted]" @ 1115, during procedure part of catheter tip broke off inside patient. Catheter was a 5fr 40cm KMP. Dr. "[redacted]" pulled out catheter from patient and saw tip of catheter broke off inside the patient, part of tip still on the wire. Surgeon OP note: with the vessel isolated proximally and distally, made a longitudinal arteriotomy, then used a plaque elevator to remove the occlusive plaque down to the profunda femoral artery extending our arteriotomy laterally and proximal to the circumflex vessels. We again removed the heavy calcified plaque and once this was done, the pericardial patch was placed over the left common femoral artery with a running 5-0 Prolene. Once this was completed, we had improved pulsatility to the left groin. Then, a figure-of-eight 6-0 Prolene was placed on the medial aspect of the vessel on the right common femoral artery. Micro access needle, then followed a micro wire, then microcatheter, then used a Glidewire to cannulate the aorta, over this a 5-French sheath. We confirmed we were intraluminal in the aorta with contrast. Next, Bentson wire was passed into the aorta and then we upsized to a short 8-French sheath. Next, we placed a figure-of-eight 6-0 Prolene in the medial aspect of the left common femoral artery as a stay stitch to wish to close after access. A micro access needle was passed in the left side and a microcatheter, then attempt using a J-wire, which was blunted. I then used a Glidewire to attempt traversing the left side. Contrast was used to establish a roadmap of the arteries. I was eventually able to get the Glidewire with the KMP up the left side into the aorta. I confirmed contrast in the aorta through the catheter. As the KMP catheter was attempted to be removed from the sheath over the wire in the left side, we tore the tip of the catheter off as that was wedged in the occlusive left common iliac artery. At this point, this was over an Amplatz wire. At this point, we conferred with multiple surgeons to best go forward with attempts at salvaging or removing the tip of the catheter versus trapping it and continuing on with the revascularization. The tip of the catheter was immobile as the wire was being moved in and out on fluoroscopy. I attempted angioplasty with a small balloon up to the area where the catheter tip was severed but still speared on the Amplatz wire. This did not allow for any further manipulation of the tip of the catheter, and the balloon would not track up through the left common iliac artery disease. At this point, we established 8-French sheaths on both wires, and we attempted angioplasty in the right common iliac artery, which had similar calcific occlusive disease, which was refractory to many catheters. We attempted passing a steerable sheath up the right side through a 10-French sheath and this would not pass into the aorta as expected in order to develop an antegrade track across the left common iliac artery. The right common iliac artery was angioplastied several times; however, there was still resistance in passing additional catheters and sheaths for further intervention. Due to the refractory aortoiliac occlusive disease, I decided then to stent the right common iliac artery starting in the aorta to affectively trap the severed catheter, which lay in the distal aorta into the left common iliac artery. We began with an 11 x 59 mm VBX distal to that after retrograde angiogram showed further disease of the iliac artery, which was treated with a 9 mm x 39 mm VBX stent. There was remaining disease of the distal external iliac artery, which was treated with an 8 x 15 mm Viabahn stent. At this point, completion arteriography was done showing excellent flow from the aorta down to the right common femoral artery angioplastied vessel. While access was maintained, the wire was removed from the left side to ensure that the catheter tip would not migrate. This was secured and angioplastied the proximal end of the covered stents using a 14 mm balloon to stretch out the proximal end of the 11 mm stent to 14 mm essentially trapping the severed catheter tip further into the left iliac artery and distal aorta. At this point, we removed both wires and catheters. There was a bounding pulse in the right femoral artery and there was a weak palpable pulse in the left common femoral artery.

Description of Event or Problem

"[redacted]" @ 1115, during procedure part of catheter tip broke off inside patient. Catheter was a 5fr 40cm KMP. Dr. "[redacted]" pulled out catheter from patient and saw tip of catheter broke off inside the patient, part of tip still on the wire. Surgeon OP note: with the vessel isolated proximally and distally, made a longitudinal arteriotomy, then used a plaque elevator to remove the occlusive plaque down to the profunda femoral artery extending our arteriotomy laterally and proximal to the circumflex vessels. We again removed the heavy calcified plaque and once this was done, the pericardial patch was placed over the left common femoral artery with a running 5-0 Prolene. Once this was completed, we had improved pulsatility to the left groin. Then, a figure-of-eight 6-0 Prolene was placed on the medial aspect of the vessel on the right common femoral artery. Micro access needle, then followed a micro wire, then microcatheter, then used a Glidewire to cannulate the aorta, over this a 5-French sheath. We confirmed we were intraluminal in the aorta with contrast. Next, Bentson wire was passed into the aorta and then we upsized to a short 8-French sheath. Next, we placed a figure-of-eight 6-0 Prolene in the medial aspect of the left common femoral artery as a stay stitch to wish to close after access. A micro access needle was passed in the left side and a microcatheter, then attempt using a J-wire, which was blunted. I then used a Glidewire to attempt traversing the left side. Contrast was used to establish a roadmap of the arteries. I was eventually able to get the Glidewire with the KMP up the left side into the aorta. I confirmed contrast in the aorta through the catheter. As the KMP catheter was attempted to be removed from the sheath over the wire in the left side, we tore the tip of the catheter off as that was wedged in the occlusive left common iliac artery. At this point, this was over an Amplatz wire. At this point, we conferred with multiple surgeons to best go forward with attempts at salvaging or removing the tip of the catheter versus trapping it and continuing on with the revascularization. The tip of the catheter was immobile as the wire was being moved in and out on fluoroscopy. I attempted angioplasty with a small balloon up to the area where the catheter tip was severed but still speared on the Amplatz wire. This did not allow for any further manipulation of the tip of the catheter, and the balloon would not track up through the left common iliac artery disease. At this point, we established 8-French sheaths on both wires, and we attempted angioplasty in the right common iliac artery, which had similar calcific occlusive disease, which was refractory to many catheters. We attempted passing a steerable sheath up the right side through a 10-French sheath and this would not pass into the aorta as expected in order to develop an antegrade track across the left common iliac artery. The right common iliac artery was angioplastied several times; however, there was still resistance in passing additional catheters and sheaths for further intervention. Due to the refractory aortoiliac occlusive disease, I decided then to stent the right common iliac artery starting in the aorta to affectively trap the severed catheter, which lay in the distal aorta into the left common iliac artery. We began with an 11 x 59 mm VBX distal to that after retrograde angiogram showed further disease of the iliac artery, which was treated with a 9 mm x 39 mm VBX stent. There was remaining disease of the distal external iliac artery, which was treated with an 8 x 15 mm Viabahn stent. At this point, completion arteriography was done showing excellent flow from the aorta down to the right common femoral artery angioplastied vessel. While access was maintained, the wire was removed from the left side to ensure that the catheter tip would not migrate. This was secured and angioplastied the proximal end of the covered stents using a 14 mm balloon to stretch out the proximal end of the 11 mm stent to 14 mm essentially trapping the severed catheter tip further into the left iliac artery and distal aorta. At this point, we removed both wires and catheters. There was a bounding pulse in the right femoral artery and there was a weak palpable pulse in the left common femoral artery.