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 tip separated from the embolectomy catheter was confirmed.As received, the spring tip was stretched.The balloon with distal windings were pulled out from proximal windings and not returned.What appeared to be trace adhesive was observed at the distal end of the stretched spring.No other visible damage was observed from catheter body.The device history record review was not completed as a lot number was not provided.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 or design defect.As part of the manufacturing process 100% of the units undergo a visual and balloon inflation inspection.The instructions for use also contains the following warnings and precautions: 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.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.

• 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: 23335993
• Report Number: 2015691-2025-08643
• Device Sequence Number: 9470951
• 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): 01/13/2026

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: 01/12/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (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