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

Model Number	120602F
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
Additional Manufacturer Narrative
The device evaluation is anticipated.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.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.
Event or Problem Description
It was reported that during use of the embolectomy catheter, the tip became separated.The issue occurred when attempting to pass the embolectomy catheter distally in the ulnar, and the user was met with significant resistance pulling back.The patient required a cut down of the ulnar artery to retrieve the tip of the catheter.There was no patient injury.
Additional Manufacturer Narrative
One model 120602f catheter was returned for evaluation.The customer report of separated tip of the embolectomy catheter was confirmed.As received, the spring tip was stretched.Catheter body, under proximal balloon windings, was broke.Surfaces at the break appeared to match up.Proximal balloon windings was partially unraveled.Distal windings and balloon were intact.No other visible damage was observed from catheter body.The lot number was not provided thus a device history record was not reviewed.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.As part of the manufacturing process, 100% of the units undergo an inflation test and visual inspection.The instructions for use also contain the following warnings and precautions: 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.

• 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): BD APM; 17200 laguna canyon rd; irvine CA 92603
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23335991
• Report Number: 2015691-2025-08642
• Device Sequence Number: 9470949
• Product Code: DXE
• UDI-Device Identifier: 00690103043273
• UDI-Public: 00690103043273
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 120602F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Weight: 56 KG