MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; JOURNEY ANGLED TIP

Catalog Number M001391290

Device Problems Break (1069); Device, or device fragments remain in patient (1527); Tip breakage (1638); Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Aneurysm (1708)

Event Date 11/01/2018

Event Type  Injury  

Event Description

During operating room for an 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: BOSTON SCIENTIFIC
• Type of Device: JOURNEY ANGLED TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 8068995
• MDR Text Key: 127117735
• Report Number: 8068995
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729789857
• UDI-Public: 08714729789857
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Catalogue Number: M001391290
• Device Lot Number: 22748120
• 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: 11/02/2018
• Distributor Facility Aware Date: 11/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR