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

Model Number 220804F

Device Problem Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2020

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10851262
• MDR Text Key: 216627078
• Report Number: 10851262
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00690103043594
• UDI-Public: (01)00690103043594(17)220127(11)191029(10)62684326
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 220804F
• Device Catalogue Number: 220804F
• Device Lot Number: 62684326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 74