MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number	1013730
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure to treat an occluded lesion in the anterior tibial artery with moderate calcification.The ht command 18 guidewire (gw) was advanced through the 6fr short sheath sheath, but met heavy resistance, so it was removed from the anatomy.Outside the anatomy, the coating of the tip of the gw was noted to be peeling off.No part of the peeled material was in the patient anatomy.There was no adverse patient effect and no clinically significant delay reported in the procedure.A non-abbott gw was used to continue the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported peeled/delaminated was confirmed.The reported difficult to advance could not be tested due to the device condition.Additionally it was noted that the polymer was deformed, stretched, and scratched.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 incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to advance; however, the reported peeled/delaminated polymer appears to be related to operational context.Factors that may contribute to difficulty advancing the guide wire through the catheter include, but are not limited to, inner diameter of the guide catheter, outer diameter of the guide wire, buildup of procedural contaminants, and/or damage to the guide catheter or guide wire.Based on the information provided and return analysis, it is unknown what may have caused or contributed to the reported difficult to advance.Additionally, the deformed, stretched, and scratched polymer noted during return analysis indicates the wire interacted with an accessory device.It is likely that manipulation of the guide wire, when met with resistance, resulted in the reported peeled/delaminated polymer.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE COMMAND 18 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: 16019223
• Report Number: 2024168-2022-12910
• Device Sequence Number: 17616406
• Product Code: DQX
• UDI-Device Identifier: 08717648212123
• UDI-Public: 08717648212123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152404
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 08/31/2023
• Device Model Number: 1013730
• Device Catalogue Number: 1013730
• Device Lot Number: 1091661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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
• Patient Sex: Unknown