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MalfunctionMMX

ATRIEVE VASCULAR SNARE KIT 6FR

Received Oct 2, 2023 · Event occurred Sep 1, 2023

Report 0001625425-2023-01209 · MDR key 17858266

Device

Generic name

Atrieve Vascular Snare Kit

Model number

382006020

Lot number

11400479

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Foreign Body In Patient
  • Insufficient Information
  • Foreign Body In Patient
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. ONE USED SAMPLE WAS RETURNED TO ARGON FROM THE CUSTOMER. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE. THE VISUAL INSPECTION ESTABLISHED THAT THERE WAS NO RADIOPAQUE BAND ON THE DELIVERY CATHETER SHEATHE. THIS MAY BE DUE TO THE I.D. OF THE RADIOPAQUE BAND BEING OVER TOLERANCE DURING SWAGING. THIS WOULD ALLOW FOR POSSIBLE CRACKING IN THE BAND WHICH MAY LEAD TO DETACHMENT DURING PROCEDURE. IT MAY ALSO BE POSSIBLE THAT IF THE DEVICE WAS STUCK AT ANYTIME AND EXCESSIVE FORCE WAS USED TO RETRIEVE THE SHEATH, THE RADIOPAQUE BAND HAS THE POSSIBILITY TO BE FORCED OFF DURING THE EVENT. SINCE THIS IS THE ONLY COMPLAINT FROM THIS PART AND LOT, THIS WILL BE TREATED AS AN ISOLATED OCCURRENCE SO NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. HOWEVER, ARGON WILL CONTINUE TO MONITOR FOR RECURRENCE.

Description of Event or Problem

THE ATRIEVE WAS OPENED TO USE FOR EVAR PROCEDURE. THE STENT GRAFT GOING TO USE FOR EVAR WAS ENDURANT BY MEDTRONIC. A 7F/100CMGUIDING CATHETER PARENT FROM MEDIKIT WAS INSERTED TO THE PATIENT FROM BRACHIAL ARTERY. TO PULL THOUGH, THE ATRIEVE DELIVERY CATHETER WAS INSERTED TO THE PARENT GUIDING CATHETER AND PLACED IN THE TARGET AREA. AND THEN, THE ATRIEVE SNARE WAS INSERTED TO THE GUIDING CATHETER. AT THAT TIME, THE PHYSICIAN NOTICED THAT THE RADIOPAQUE BAND ON THE TIP OF THE DELIVERY CATHETER HAD COME OFF IN THE BLOOD VESSEL. IT BECAME UNABLE TO CONFIRM THE PLACEMENT OF THE TIP OF THE DELIVERY CATHETER WITHOUT THE RADIOPAQUE BAND, THEREFORE, THE DELIVERY CATHETER AND THE SNARE WAS REMOVED. AFTER THE PROCEDURE, IT WAS CONFIRMED THE DETACHED RADIOPAQUE BAND REMAINED AND STAYED AT TH 9 INSIDE OF THE PATIENT. THE PATIENT IS STABLE AND ADDITIONAL TREATMENT FOR THE REMAINING RADIOPAQUE BAND IN THE PATIENT HAS NOT BEEN TAKEN.

Description of Event or Problem

THE ATRIEVE WAS OPENED TO USE FOR EVAR PROCEDURE. THE STENT GRAFT GOING TO USE FOR EVAR WAS ENDURANT BY MEDTRONIC. A 7F/100CMGUIDING CATHETER PARENT FROM MEDIKIT WAS INSERTED TO THE PATIENT FROM BRACHIAL ARTERY. TO PULL THOUGH, THE ATRIEVE DELIVERY CATHETER WAS INSERTED TO THE PARENT GUIDING CATHETER AND PLACED IN THE TARGET AREA. AND THEN, THE ATRIEVE SNARE WAS INSERTED TO THE GUIDING CATHETER. AT THAT TIME, THE PHYSICIAN NOTICED THAT THE RADIOPAQUE BAND ON THE TIP OF THE DELIVERY CATHETER HAD COME OFF IN THE BLOOD VESSEL. IT BECAME UNABLE TO CONFIRM THE PLACEMENT OF THE TIP OF THE DELIVERY CATHETER WITHOUT THE RADIOPAQUE BAND, THEREFORE, THE DELIVERY CATHETER AND THE SNARE WAS REMOVED. AFTER THE PROCEDURE, IT WAS CONFIRMED THE DETACHED RADIOPAQUE BAND REMAINED AND STAYED AT TH 9 INSIDE OF THE PATIENT. THE PATIENT IS STABLE AND ADDITIONAL TREATMENT FOR THE REMAINING RADIOPAQUE BAND IN THE PATIENT HAS NOT BEEN TAKEN.

Additional Manufacturer Narrative

THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY.