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

Model Number	12TLW405F35
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with a 12tlw405f35 fogarty catheter, the balloon sheered off and was left inside the patient.Unknowingly, it was found a week later during a de-clot procedure (date not provided).This required another procedure and the foreign body was removed from the patient.The original intended procedure was a left forearm loop graft de-clot.This event took place in the month of april.The device is available for return.
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 results become available.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Additional Manufacturer Narrative
No product was returned for evaluation.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.A device history record review was completed and documented that the device met all specifications upon distribution.The complaint affected unit was not returned for evaluation; therefore, a product non-conformance or device failure could not be confirmed.As part of the manufacturing process a 100% of the units go through a balloon winding and full visual inspection process performed.The ifu provides warnings and cautions related to the balloon and the handling of the catheter as a guideline to follow 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.The possibility of balloon rupture must be taken into account when considering the risks involved in any embolectomy procedure.To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter.The catheter should be inspected with the balloon inflated during purging.A balloon that does not inflate, leaks, or inflates in a grossly asymmetric (eccentric) manner should not be used.Remove the occlusive material by gently withdrawing the catheter.During withdrawal, it is important to adjust the balloon diameter to the varying arterial diameters by controlling the inflation volume.

• Brand Name: FOGARTY
• 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: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20081389
• Report Number: 2015691-2024-06653
• Device Sequence Number: 18095432
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)260108(11)231010(10)65314440
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K892410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2026
• Device Model Number: 12TLW405F35
• Device Lot Number: 65314440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown