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

Model Number	140806
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during use in patient this fogarty corkscrew catheter could not be removed from the sheath introducer when attempting to withdraw the catheter from the patient.As a result the catheter was withdrawn along with the introducer.Hemostasis was achieved and no additional incision or extension of hospitalization was required due to this issue.There was no allegation of patient injury.The device was not available for evaluation since it was discarded at the hospital.
Additional Manufacturer Narrative
There was no product evaluation as the device was discarded and not returned.Without its return, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.The device history record review was not completed as no lot number was provided.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.

• Brand Name: FOGARTY CORKSCREW
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23408284
• Report Number: 2015691-2025-08877
• Device Sequence Number: 9076069
• Product Code: DXE
• UDI-Device Identifier: 00690103042412
• UDI-Public: 00690103042412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K901625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: 140806
• Was Device Available for Evaluation?: No
• 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: 10/08/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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