MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE SUPRA CORE ¿ 35 GUIDE WIRE WITH MICROGLIDE® COATING

Model Number	1002703-01
Medical Device Problem Codes	Product Quality Problem (1506); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left common iliac artery.A hi torque supracore guide wire was being advanced with an unspecified catheter when a bump and missing coating on a portion of the guide wire that is outside the patient anatomy was noted.Another supracore guide wire was used to successfully complete the procedure.There were no adverse patient effects 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.The reported irregular appearance and materials split/cut or torn materials were unable to be 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 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 that the reported irregular appearance and materials split/cut or torn appears to be related to case circumstances of the procedure.Based on the reported information and returned analysis, it is likely that the reported bump on the guide wire is the proximal solder joint as it is located towards the proximal end of the guide wire versus on the distal end as other abbott guide wires.Additionally, the missing coating that was reported is intended to be free of teflon coating due to the proximal solder joint location.The noted bends and stretched coils on the guide wire likely occurred during packing for return analysis.The noted teflon coating damage was likely caused by the torque device used in the procedure and/or other accessory devices used in the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE SUPRA CORE ¿ 35 GUIDE WIRE WITH MICROGLIDE® COATING
• 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: 12541657
• Report Number: 2024168-2021-08693
• Device Sequence Number: 17477403
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: 08717648032998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K980119
• 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): 12/10/2021

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: 03/31/2023
• Device Model Number: 1002703-01
• Device Catalogue Number: 1002703-01
• Device Lot Number: 1040661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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: Male