inforMED
MalfunctionMMX

ATRIEVE VASCULAR SNARE KIT 3.2FR

Received Dec 8, 2021 · Event occurred Oct 27, 2021

Report 0001625425-2021-01208 · MDR key 12965712

Device

Generic name

Atrieve

Model number

381003008

Catalog number

381003008

Lot number

11351925

Product problems

  • Failure to Advance
  • Mechanical Jam

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

DURING USE, THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE INTO THE DELIVERY CATHETER WITH USING THE INTRODUCER, HOWEVER, THE SNARE GOT STUCKED AND UNABLE TO ADVANCE. THEN THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE TO THE DELIVERY CATHETER FROM THE DISTAL TIP OF THE DELIVERY CATHETER, BUT THE SNARE GOT STUCKED AGAIN. UNABLE TO SET THE SNARE IN THE DELIVERY CATHETER. THE ATRIEVE WAS SWITCHED TO ANOTHER NEW ONE AND THE PROCEDURE WAS COMPLETED.

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. ONE UNSEALED ATRIEVE WAS RETURNED FOR REVIEW BY THE CUSTOMER. A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCT. THE VISUAL INSPECTION ESTABLISHED THAT THERE WAS NO EXTERNAL DAMAGE FOUND ON THE DEVICE DURING THE INVESTIGATION. THE PART WAS MEASURED ON SEVERAL PLACES SUCH AS THE PROXIMAL, MIDDLE, DISTAL, TAPER, AND SOLDER. THE MEASUREMENTS WERE WITHIN SPECIFICATION ACCORDING TO DRAWINGS. WITH ONLY THE ATRIEVE RETURNED THE DELIVERY CATHETER SHEATHE CANNOT BE CHECKED FOR ANY DEFECTS. SINCE THERE WAS NO ISSUE OBSERVED DURING THE INVESTIGATION, NO CORRECTIVE ACTION WILL BE DONE AT THIS TIME.

Description of Event or Problem

DURING USE, THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE INTO THE DELIVERY CATHETER WITH USING THE INTRODUCER, HOWEVER, THE SNARE GOT STUCKED AND UNABLE TO ADVANCE. THEN THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE TO THE DELIVERY CATHETER FROM THE DISTAL TIP OF THE DELIVERY CATHETER, BUT THE SNARE GOT STUCKED AGAIN. UNABLE TO SET THE SNARE IN THE DELIVERY CATHETER. THE ATRIEVE WAS SWITCHED TO ANOTHER NEW ONE AND THE PROCEDURE WAS COMPLETED.

Additional Manufacturer Narrative

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

Description of Event or Problem

DURING USE, THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE INTO THE DELIVERY CATHETER WITH USING THE INTRODUCER, HOWEVER, THE SNARE GOT STUCKED AND UNABLE TO ADVANCE. THEN THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE TO THE DELIVERY CATHETER FROM THE DISTAL TIP OF THE DELIVERY CATHETER, BUT THE SNARE GOT STUCKED AGAIN. UNABLE TO SET THE SNARE IN THE DELIVERY CATHETER. THE ATRIEVE WAS SWITCHED TO ANOTHER NEW ONE AND THE PROCEDURE WAS COMPLETED.