MAUDE Adverse Event Report: ABBOTT VASCULAR 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

Model Number	1020010
Medical Device Problem Codes	Break (1069); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left circumflex artery using a.014 ht turntrac flex guide wire.As the guide wire was being removed, the radiopaque tip could still be seen on angiography, indicating a separation.A guide catheter was advanced to remove the separated portion and the guide catheter and guide wire were removed as a unit.Additionally, after removal the coils were noted to be elongated/stretched.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported stretched coils were confirmed.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 and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported stretched coils appear to be related to operational circumstances of the procedure.In this case, it is likely that during retraction, the guide wire became caught on the anatomical and/or other devices used in the procedure resulting in the reported stretched coils.Since there were no separations reported by the account, it is likely that the noted separation and core bends likely occurred during packing for return analysis.The noted teflon coating damage likely occurred during retraction through the torque device and/or other accessory devices used in the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B1: adverse event was removed b2: required intervention was removed.H1: type of reportable event changed to malfunction.H6: medical device problem code 1562 was removed.H6: health effect - impact code 4641 was removed.
Event or Problem Description
The following additional information was received: the.014 ht turntrac flex guide wire did not separate, the tip coils stretched.The guide catheter was simply advanced to the stretched guide wire coils and the guide wire and guide catheter were removed together as a unit.No additional information was provided.Return device analysis identified the core was separated, but the guide wire was in one piece.

• Brand Name: 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11939345
• Report Number: 2024168-2021-04667
• Device Sequence Number: 11027965
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: 08717648222641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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 Expiration Date: 10/31/2021
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Device Lot Number: 9112061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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