MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE PILOT GUIDE WIRE

Catalog Number	1010480-H
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date (reportedly occurred 5 years ago).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was advanced resistance was met with the anatomy resulting in the reported failure to advance.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a percutaneous transluminal intervention to treat a chronic total occlusion in the distal right coronary artery, the pilot guide wire was advanced to the distal posterior descending coronary artery when a perforation occurred.The perforation was treated with a collagen plug.The patient is reportedly well and the event resolved.There was no additional information provided regarding this issue.

• Brand Name: HI-TORQUE PILOT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7241411
• Report Number: 2024168-2018-00808
• Device Sequence Number: 16390506
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: 08717648073854
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060449
• 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): 02/05/2018

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: 1010480-H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/05/2018
• 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: 78 YR