MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FOGARTY; CATHETER, IRRIGATION

Model Number	220804F
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Per the reporter, we were doing a femoral thrombectomy using a # 4 long fogarty catheter and part of the balloon busted and potentially remained in the patient.We have saved the balloon and the wrapper for further investigation.Previous day surgeon's progress note: legs are cool, but perfused.Right groin incision is clean, dry, and intact.Will move lower extremity but minimal strength.Stable perfusion to both feet.High risk for higher amputation bilaterally.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10851262
• Report Number: 10851262
• Device Sequence Number: 16951480
• Product Code: GBX
• UDI-Device Identifier: 00690103043594
• UDI-Public: (01)00690103043594(17)220127(11)191029(10)62684326
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2020
• Report Date (Section F): 10/30/2020

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: 220804F
• Device Catalogue Number: 220804F
• Device Lot Number: 62684326
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 10/30/2020