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

Model Number	120404F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use during the inflation test, the tip of this fogarty catheter was detached when the balloon was inflated.There were no patient complications reported.
Additional Manufacturer Narrative
The device is anticipated to be returned for evaluation but has not yet been received.A supplemental report will be forthcoming when the investigation is completed.A device history record review was unable to be completed as the lot number is unknown.The full udi number is not available, as the lot number is unknown.The primary device identifier (di) number was provided.
Additional Manufacturer Narrative
One 120404f catheter without any attached components was returned for evaluation.The reported issue that the catheter tip was detached was not confirmed.As received, a kink was observed on catheter body at 5 mm proximal from the tip.When the balloon was inflated, the distal windings slipped at the catheter tip.Although the distal windings slipped at the catheter tip, the balloon inflated and remained inflated.There was no visible damage or inconsistency observed from the proximal windings.This event is no longer considered reportable and a corrected supplemental report is being submitted.

• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 21126728
• Report Number: 2015691-2025-00230
• Device Sequence Number: 12468754
• Product Code: DXE
• UDI-Device Identifier: 00690103043266
• UDI-Public: 00690103043266
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 120404F
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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