MAUDE Adverse Event Report: AV-TEMECULA-CT 0.014 HI-TORQUE (HT); GUIDE WIRE

Catalog Number	1020013
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
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.(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during tip shaping resulted in the reported kinked tip.It should be noted the hi-torque turntrac guide wire instructions for use (ifu) states: guide wires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage.Do not use damaged guide wires.Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.The ifu deviation does not appear to have directly caused or contributed to 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 procedure was to treat a bifurcation lesion in the left anterior descending diagonal branch.During shaping of the turntrac guide wire, the guide wire tip kinked, however the guide wire was continued to be used.The guide wire was advanced and a stent was implanted.Upon removal of the guide wire, the guide wire was caught on a stent and resistance was felt.The guide wire was removed without further issues.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

• Brand Name: 0.014 HI-TORQUE (HT)
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7630844
• Report Number: 2024168-2018-04863
• Device Sequence Number: 16440893
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103101
• 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): 06/22/2018

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 1020013
• Device Lot Number: 8041061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1