MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR ASAHI MIRACLEBROS 3 300CM; PTCA GUIDE WIRE

Model Number	REF 14937-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
During heart catheterization, an abbott asahi miraclebros 3 300cm ptca guide wire broke off in the right coronary artery and caused a dissection, requiring covering with a stent.Not all of the broken wire was able to be retrieved, and remains in patient under stent.

• Brand Name: ABBOTT VASCULAR ASAHI MIRACLEBROS 3 300CM
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054 2807
• MDR Report Key: 5429917
• Report Number: 5429917
• Device Sequence Number: 927977
• Product Code: DQX
• UDI-Device Identifier: 04547327056021
• UDI-Public: (01)04547327056021
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/04/2016
• Report Date (Section F): 02/04/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: REF 14937-01
• Device Lot Number: 140821A121
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2016
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 120
• Date Report Sent to FDA: 02/04/2016