MAUDE Adverse Event Report: BOSTON SCIENTIFIC PT GRAPHIX INTERMEDIATE GUIDEWIRE

Model Number	08714729254928
Health Effect - Clinical Codes	Chest Pain (1776); Stenosis (2263); Foreign Body In Patient (2687)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt hospitalized with an acute chest pain syndrome and ruled in for a non-stemi.Physician attempted to reposition the pt graphix guidewire into the posterior descending coronary artery which had a severe ostial stenosis.When the wire was being withdrawn into the distal right coronary artery, the guidewire became entrapped at the distal right coronary artery, the guidewire became entrapped at the distal stent edge and could no longer be manipulated.Physician attempted to dislodge the guidewire and advance it back into the distal vessel, but it would not move.The wire was stuck at the distal edge.The wire was removed with multiple manipulation and 2 distal fragments were present in the distal right coronary artery with no flow limitation and no evidence of thrombosis.The guidewire fragment was entrapped at the distal stent edge in the distal right coronary artery.After balloon angioplasty at this site, part of the wire fragment embolized to the distal posterolateral branch.Part of the wire fragment remained attached to the distal stent edge.This was treated with another drug-eluting stent in the distal right coronary artery to trap the guidewire fragment against the vessel wall with a good angiographic result.

• Brand Name: PT GRAPHIX INTERMEDIATE GUIDEWIRE
• Common Device Name: PT GRAPHIX INTERMEDIATE GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC; global park; heredia, cr
• MDR Report Key: 6217865
• Report Number: MW5067003
• Device Sequence Number: 876891
• Product Code: DQX
• UDI-Device Identifier: 08714729254928
• UDI-Public: 08714729254928
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/29/2016

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: 06/27/2018
• Device Model Number: 08714729254928
• Device Catalogue Number: H74914902011
• Device Lot Number: 19419378
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2016
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 105