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

Model Number	120602F
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon of a 120602f catheter popped during a thrombectomy surgery.The wire then got stuck in the artery.Additional information was requested, but not provided.
Additional Manufacturer Narrative
Multiple attempts were made for additional information and to secure return of the device however the customer has not responded nor sent the device back 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.No corrective actions will be taken at this time.A supplemental report will be forthcoming if additional information or device is provided.
Additional Manufacturer Narrative
Device was returned on 18dec2024.It was previously reported that the device would not be returned.A product evaluation was completed on the returned 120602f.The reported event of balloon issue was confirmed.Spring tip was stretched and broken.Balloon and distal windings were missing.Proximal windings was unraveled.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 catheter.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As part of the manufacturing process, 100% of the units go through a balloon inflation and visual inspection.A device history record review was completed and it was documented that device met all specifications upon distribution.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.
Additional Manufacturer Narrative
Additional information was received.Per follow up with customer, the date of occurrence was (b)(6) 2024.The balloon was tested prior to insertion.The defective catheter was removed by the surgeon and another catheter was used.There were no additional unplanned procedures.There was no patient injury.The additional information was initially reported under report id: 2015691-2024-09017 which was determined to be a duplicate of this report.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20622506
• Report Number: 2015691-2024-08383
• Device Sequence Number: 8749379
• Product Code: DXE
• UDI-Device Identifier: 00690103043273
• UDI-Public: (01)00690103043273(17)260530(11)240229(10)65607068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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
• Device Expiration Date: 05/30/2026
• Device Model Number: 120602F
• Device Lot Number: 65607068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 07/02/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/16/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown