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

Model Number	120602F
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	12/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during use in patient of this fogarty catheter, the balloon got stuck and detached being not visible anymore at popliteal level, remaining in the vessel (manufacturer's medwatch#: 60608).A new device was used and the same issue occurred (manufacturer's medwatch#: 60609).Balloons were able to be removed from patient, however not all the balloon material could be totally withdrawn.There was no allegation of patient injury.As a summary, two medwatch reports were submitted (ref.(b)(4).
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product 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 or Problem Description
As reported, during use in patient of this fogarty catheter, the balloon got stuck and detached being not visible anymore at popliteal level, remaining in the vessel (report no 2015691-2025-00498).A new device was used and the same issue occurred (report no 2015691-2025-00499).Balloons were able to be removed from patient, however, not all the balloon material could be totally withdrawn.Procedure to remove balloons is not known.There was no allegation of patient injury.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation), h10 (related report number) updated section b5, h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Despite repeated attempts to receive the device, no sample for evaluation was received.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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.As part of the manufacturing process the units go through a balloon winding and full visual inspection process.
Additional Manufacturer Narrative
Added information to section d9, h6 (type of investigation), h6 (device code) updated section h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was received for evaluation.The report of balloon issue was confirmed.The balloon was found to be ruptured.Rupture edges did not appear to match up.No visible damage was found from windings or catheter body.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.".As part of the manufacturing process the units go through balloon and winding inspection process.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.Corrected data: based on further review, corrected sections b1, b2, b5 and h1.The information was inadvertently omitted from the earlier reports but it does not change the event, outcome, or conclusions previously submitted.
Event or Problem Description
As reported, during use in patient of this fogarty catheter, the balloon got stuck and detached being not visible anymore at popliteal level, remaining in the vessel (report no 2015691-2025-00498).A new device was used and the same issue occurred (report no 2015691-2025-00499).Balloons were able to be removed from patient, however not all the balloon material could be totally withdrawn.Procedure to remove balloons is not known.The device was received for evaluation.The balloon was found to be ruptured at the central area.Rupture edges did not appear to match up.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• 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: 21250982
• Report Number: 2015691-2025-00499
• Device Sequence Number: 9116841
• Product Code: DXE
• UDI-Device Identifier: 00690103043273
• UDI-Public: (01)00690103043273(17)260208(11)231110(10)65438411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2026
• Device Model Number: 120602F
• Device Lot Number: 65438411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 04/07/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/05/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 46 KG