MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; CATHETERS, EMBOLECTOMY

Model Number 120804FFP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

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.

Event Description

As reported, after exposing the femoropopliteal bypass during retrograde thrombectomy, this fogarty embolectomy catheter (manufacturer reference (b)(4), medwatch #34905) broke off into two pieces at the level of the a femoralis communis, remaining inside the patient.The catheter had been drained from a femoralis communis into a femoralis profunda.A percutaneous intervention was required to remove the broken part endovascularly with a snare.Another fogarty catheter (manufacturer reference (b)(4), medwatch #34984) was used, but the balloon came off before using it in patient.There was no allegation of patient injury.The devices were available for evaluation.As a summary, two medwatch report are being submitted, one for each device (medwatch #34905 and #34984).

Manufacturer Narrative

One fogarty catheter was received by our product evaluation laboratory for a full examination.The report of broken catheter was confirmed.As received, catheter body tube was completely broken off next to proximal winding.The cross surface of broken tube was rough.The edges of the broken section appeared to match at the break site.Proximal winding was received partially unraveled.No other visible damage was observed from balloon and distal winding.No other visible damage from catheter body was observed.Per the 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.".

Manufacturer Narrative

The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering investigation, the units go through a visual inspection as part of the manufacturing process.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETERS, EMBOLECTOMY
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17621735
• MDR Text Key: 322191837
• Report Number: 2015691-2023-15465
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2023

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 Model Number: 120804FFP
• Device Lot Number: 64393904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/28/2023; 10/10/2023
• Supplement Dates FDA Received: 09/22/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2023
• 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: 74 YR