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

Model Number	1020013
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, moderately tortuous, 90% stenosed, de novo lesion in the right coronary artery (rca).An 014 ht turntrac guide wire (gw) was advanced into the posterior lateral branch and positioned to add support in the artery.During removal of the gw, it was noted that the distal portion separated and possibly some coating peeled from the wire.The separated wire and coating were snared and removed from the anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information regarding this issue was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported separation was confirmed.There was no peeling noted on the guide wire as reported.The coils were noted to be stretched and likely presumed and reported as peeling.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 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 guide wire separation and noted stretched coils appear to be related to case circumstances of the procedure.In this case, it is likely that during the procedure, the core became damaged and separated but remained in one piece resulting in the noted stretched coils during retraction and the appearance of peeling or delamination.The separated wire was snared and removed from the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13006754
• Report Number: 2024168-2021-11611
• Device Sequence Number: 1726705
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 01/31/2022
• Device Model Number: 1020013
• Device Catalogue Number: 1020013
• Device Lot Number: 0020361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTIMES1.25X15MM; FIELDER FC WIRE; FIREHAWK 2.5X18 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown