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

Model Number	120804F
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon on the fogarty catheter broke and remained inside the patient.

• Brand Name: EDWARDS LIFESCIENCES FOGARTY
• Common Device Name: CATHETER, IRRIGATION, FOGARTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 8343631
• Report Number: MW5084112
• Device Sequence Number: 13858057
• Product Code: GBX
• UDI-Device Identifier: 00690103043303
• UDI-Public: (01)00690103043303
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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 Expiration Date: 12/01/2019
• Device Model Number: 120804F
• Device Catalogue Number: 120804F
• Device Lot Number: 61027249
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability