MAUDE Adverse Event Report: BOSTON SCIENTIFIC PT GRAPHIX 0.014 X 182 CM; CATHETER GUIDEWIRE

Catalog Number	H74914902011
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Pt was having stent placed.Unfortunately, while removing the wire the prolapsed portion of the wire apparently went under the stent strut, caught the wire, accordioned the stent slightly and trapped the wire.Considerable efforts were undertaken to attempt to remove the wire.Ultimately the tip of the wire finally broke and remains in the struts of the 2.5 x 23 xience stent, distally.The pt will f/u clinically for further decisions/ options for this in the future.

• Brand Name: PT GRAPHIX 0.014 X 182 CM
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC; global park; heredia, cr
• MDR Report Key: 5764660
• Report Number: MW5063197
• Device Sequence Number: 13608556
• Product Code: DQX
• UDI-Device Identifier: 08714729254928
• UDI-Public: 08714729254928
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2016

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: 03/17/2018
• Device Catalogue Number: H74914902011
• Device Lot Number: 19048502
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2016
• 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: Other
• Patient Age: 71 YR