MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER, FOGARTY BILIARY BALLOON PROBE; CATHETER, EMBOLECTOMY

Model Number 120803FP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pseudoaneurysm (2605)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

As reported, during use in patient in an embolectomy procedure in the tibial vessels with this fogarty catheter, the catheter broke during retraction.It was found later via angiography, that the distal portion of the catheter remained in the interosseous artery.There was also reported patient injury in the form of pseudoaneurism due to a rupture of the arterial wall.The fragment was recovered during a second intervention in the angiography room.After this secondary procedure, the patient outcome was good.The device was partially available for evaluation.

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of this monthly review.The product is expected to be returned for analysis; however, it has not yet been received.

Manufacturer Narrative

Updated: h6 (investigation findings, investigation conclusions).Added: h6 (component code, type of investigation).H10 manufacturer narrative: the manufacturing process have the controls to detect conditions related to balloon or spring tip.The units go through a final visual and inflation inspection process.In this inspection process, the appearance of the catheter body is verified, and it should not have bends, wrinkles, cuts, contamination, stains or discoloration or ripples.Also, the windings of the balloon are inspected, for conditions such as loose windings or strands, separations, contamination, slipped, defective, exposed shoulder and / or excess adhesive.In addition, in the instructions for use (ifu) is indicated that the balloon rupture and catheter separation are the most frequent causes of reported failures as a result of excessive pull force applied to remove adherent material.It is specified that to minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation and pull force for each size catheter must not be exceed.Based on the available information there is no evidence that supports or confirms theses failure modes are associated to a manufacturing or design defect.

Manufacturer Narrative

Added: d9 (device availability), h3 (device evaluated by manufacturer) , h4 (expiration date), h4 (device manufacturer date), h6 (type of investigation).The device was sent to our product evaluation laboratory for a full evaluation.Customer report of "catheter broke" was confirmed.Balloon catheter tip with distal winding and spring tip was received.Balloon latex edge appeared rough and uneven.Balloon broken mating part with proximal winding was not returned.Spring tip noticed stretched.Per the instructions for use (ifu) "balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures." and "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter".Additionally, the manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER, FOGARTY BILIARY BALLOON PROBE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17050171
• MDR Text Key: 316504841
• Report Number: 2015691-2023-13382
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2024
• Device Model Number: 120803FP
• Device Catalogue Number: 120803FP
• Device Lot Number: 64231981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/15/2023; 07/26/2023
• Supplement Dates FDA Received: 07/07/2023; 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR