MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number	1000462H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The investigation determined the reported difficulties and treatments appear to be related to circumstances of the procedure.It should be noted the hi torque guide wire instructions for use states: if resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the heavily tortuous, heavily calcified distal right coronary artery (rca).During advancement of the balance heavyweight (bhw) guide wire through a previously implanted stent, without resistance felt, the guide wire went through the stent struts and became entangled.Force was applied while trying to remove the guide wire and this led to a separation of the guide wire.No attempts were made to snare the separated guide wire.All of the separated guide wire was successfully removed surgically from the patient's anatomy.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5955845
• Report Number: 2024168-2016-06149
• Device Sequence Number: 19181696
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: (01)08717648015489
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2016

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 Catalogue Number: 1000462H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Initial Report FDA Received Date: 09/16/2016
• 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