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); Difficult to Remove (1528); 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 heavily calcified, mildly tortuous left common iliac artery.A hi torque supracore guide wire was used with an unspecified balloon, and the devices faced resistance during removal.Then, 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 and dimensional inspection was performed on the returned guide wire.The reported irregular appearance (unraveled coils) was confirmed.The reported difficulty to remove was unable to be confirmed due to the returned condition of the guide wire.The reported split/cut or torn materials was 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 difficulty to remove, irregular appearance (unraveled coils) 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 during the procedure the device encountered resistance with the challenging anatomy and/or the balloon catheter resulting in the difficulty to remove.Manipulation of the guide wire during retraction attempts likely resulted in the reported/noted bump and unraveled coils.Additionally, per the product specification, the reported bump on the guide wire is the proximal solder joint.The missing coating that was reported is intended to be free of coating due to the proximal solder joint.The noted bends on the guide wire likely occurred during packing for return analysis.The 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: 12541556
• Report Number: 2024168-2021-08690
• Device Sequence Number: 17477402
• 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): 12/21/2021

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: 05/31/2023
• Device Model Number: 1002703-01
• Device Catalogue Number: 1002703-01
• Device Lot Number: 1063061
• 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): Initial
• 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: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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 Age: 77 YR
• Patient Sex: Female