MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FOGARTY THRU-LUMEN ENDOLECTOMY CATHETER ; CATHETER, EMBOLECTOMY

Model Number	12TLW405F35
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During embolization procedure for an av fistula, balloon on catheter ruptured.When catheter was removed from vascular site, balloon was no longer attached.Fda safety report id: (b)(4).

• Brand Name: FOGARTY THRU-LUMEN ENDOLECTOMY CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 9610903
• Report Number: MW5092368
• Device Sequence Number: 11374917
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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 Expiration Date: 01/16/2022
• Device Model Number: 12TLW405F35
• Device Catalogue Number: 12TLW405F35
• Device Lot Number: 62667400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 30 YR
• Patient Weight: 59