MAUDE Adverse Event Report: BOSTON SCIENTIFIC COMET

Model Number COMET

Device Problem Entrapment of Device (1212)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 01/17/2017

Event Type  Injury  

Event Description

While advancing comet wire in distal right coronary artery, the wire sheared off.Attempts to retrieve were unsuccessful.The pt was taken to the operating room for a procedure to remove the comet wire.

• Brand Name: COMET
• Type of Device: COMET
• Manufacturer (Section D): BOSTON SCIENTIFIC; two scimed place; maple grove MN 55311
• MDR Report Key: 6312175
• MDR Text Key: 66875712
• Report Number: 6312175
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2017,02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: COMET
• Device Catalogue Number: H7495551110
• Device Lot Number: 19893617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 116