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

Model Number	120803FP
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fogarty embolectomy catheter involved in this case was received by our product evaluation laboratory for a full evaluation.As received, the spring tip was stretched.Additionally, the balloon was found to be ruptured at central area and the spring tip wire was exposed.Balloon edges appeared to match at the ruptured region.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.No other visible damage was observed from the catheter body and windings.Based on further engineering investigation completed by the engineers in the manufacturing site, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.The manufacturing records were reviewed and there is no indication of a related non-conformance; all process parameters were met and inspections passed successfully.Based on this assessment, no further action is required at this time, however, edwards will continue to review and monitor all events.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 or Problem Description
As reported, during procedure with this fogarty embolectomy catheter, right after inflating the balloon, it burst.As per product evaluation findings, balloon was found to be ruptured at central area and the spring tip wire was exposed.There is no allegation of patient injury.Patient demographics were not provided.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER, FOGARTY BILIARY BALLOON PROBE
• Common Device Name: 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: 21283017
• Report Number: 2015691-2025-00617
• Device Sequence Number: 9529333
• Product Code: DXE
• UDI-Device Identifier: 00690103205091
• UDI-Public: (01)00690103205091(17)240601(11)220303(10)64231983
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K193379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 120803FP
• Device Lot Number: 64231983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown