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

Model Number	12TLW804F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The device history record review has not yet been completed.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 a part of the monthly review.D2b.Additional device product code: kra- catheter, continuous flush.G4.Additional pma/510k: k892410.
Event or Problem Description
It was reported that during use of this fogarty catheter in patient; the catheter body was completely detached.No further information was available at this moment.It was confirmed there was no patient injury or harm associated with the reported complaint.
Additional Manufacturer Narrative
A product evaluation was completed.Report of catheter body was completely broken off was confirmed.Catheter body was broken at approximately 4.5cm distal from y-adapter.Cross surfaces of broken section appeared uneven and rough.Catheter body appeared to match at the broken region.The device history record review was completed, and no related non-conformances were found.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.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.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.Although the failure was confirmed during product evaluation it cannot be confirmed as a manufacturing defect.The manufacturing process has the controls to detect these conditions.Since, in these procedures the units are 100% inspected according to plan specifications, the balloon is visually inspected, for inflation and deflation, the catheter is inspected for obstruction or restricted tube, for hub / shrink leakage and for bushings and tip leakage.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.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 a part of the monthly review.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km; anasco, puerto rico
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon, rd; irvine, CA 92618
• MDR Report Key: 22984255
• Report Number: 2015691-2025-07321
• Device Sequence Number: 21174945
• Product Code: DXE
• UDI-Device Identifier: 00690103043518
• UDI-Public: (01)00690103043518(17)261220(11)240920(10)65987823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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 Model Number: 12TLW804F
• Device Lot Number: 65987823
• Was Device Available for Evaluation?: Yes
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown