MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. JOURNEY ANGLED TIP; "WIRE, GUIDE, CATHETER"

Catalog Number	M001391290
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During or for a aaa endoleak repair, gaining access to the offending vessel with the intention to coil it off, the tip of a journey wire broke off in a small branch.Tip of wire remained without retrieval ability.

• Brand Name: JOURNEY ANGLED TIP
• Common Device Name: "WIRE, GUIDE, CATHETER"
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 8070926
• Report Number: MW5081255
• Device Sequence Number: 1693145
• Product Code: DQX
• UDI-Device Identifier: 08714729789857
• UDI-Public: 08714729789857
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/02/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2020
• Device Catalogue Number: M001391290
• Device Lot Number: 22748120
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2018
• 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: Required Intervention
• Patient Age: 72 YR