MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER ES GUIDE WIRE; GUIDE WIRES

Catalog Number	1011835H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: estimate.The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.It is possible that a buildup of blood and/or contrast on the guide wire resulted in the reported physical property issue (stickiness), thus resulting in the reported difficult to position and the reported difficulty to remove; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the guide wire felt very sticky.It was difficult to advance and retract other devices over the guide wire.The device was sufficiently wetted prior to use and in between devices.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER ES GUIDE WIRE
• Common Device Name: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7427055
• Report Number: 2024168-2018-02745
• Device Sequence Number: 1950362
• Product Code: DQX
• UDI-Device Identifier: 08717648116117
• UDI-Public: 08717648116117
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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 Catalogue Number: 1011835H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1