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	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported detachment was able to be confirmed.The reported difficulty to remove was unable to be replicated in a testing environment due to the condition of the returned device.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.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 performed to treat a lesion in the circumflex artery with moderate tortuosity and moderate calcification.A hi-torque turntrac guide wire became caught with a micro-catheter during removal.Both devices were removed from the patient as a single unit.Reportedly, the distal part of the guide wire was sticking out and it was pulled out from the distal end when the tip became detached outside the patient's anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The guide wire was sent to scanning electron microscopy (sem) for further analysis.The results concluded the core separated at the tip solder.

• 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: 7635301
• Report Number: 2024168-2018-04975
• Device Sequence Number: 1645458
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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?: Yes
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR