MAUDE Adverse Event Report: ABBOTT ABBOTT; MINI VISION CORONARY STENT

Model Number	1007821-15
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
While advancing stent catheter over an interventional wire, the shaft of the stent catheter broke and was removed without incident to pt.

• Brand Name: ABBOTT
• Common Device Name: MINI VISION CORONARY STENT
• Manufacturer (Section D): ABBOTT; santa clara CA 95054
• MDR Report Key: 5875330
• Report Number: MW5064077
• Device Sequence Number: 670942
• Product Code: MAF
• UDI-Device Identifier: 08717648049392
• UDI-Public: (01)08717648049392
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/09/2016

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: 02/28/2019
• Device Model Number: 1007821-15
• Device Lot Number: 6031641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 52