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

Model Number 140808

Device Problem Break (1069)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

As reported, during use in patient of this fogarty corkscrew catheter, the distal tip was bent and the handle did not work.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was available for evaluation.

Manufacturer Narrative

The fogarty corkscrew catheter was received by our by our product evaluation laboratory for a full examination.The report of distal tip bent was confirmed.However, report of "handle did not work" was unable to be confirmed.The distal tip was received kinked/bent and the spiral cable was exposed through a tear of approximately 1mm in length in the latex membrane.The edges of the torn region appeared to match up.There was no visible damage observed to the catheter body.It was able to move the thumb slide on the handle forwards and backwards and the membrane extended and contracted respectively.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.A visual and functional inspection is performed to the catheters as part of the manufacturing process.The ifu was reviewed and it indicates: " exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation." and " to minimize the risk of vessel or membrane damage, do not exceed the maximum recommended pull force".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.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• 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: 18787815
• MDR Text Key: 336341038
• Report Number: 2015691-2024-01377
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other
• Type of Report: Initial
• Report Date: 02/27/2024

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: 140808
• Device Lot Number: 64997508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2023
• 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