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

Model Number	1002703-02
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire.The reported break and 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 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 break and stretched coils appears to be related to operational circumstances of the procedure.In this case, based on the limited information provided by the account, it is likely that manipulation of the guide wire during the advancement and/or the procedure, the guide wire¿s coils became stretched against the anatomy and or other devices.Further manipulation of the guide wire likely resulted in the coil break, subsequent coil damages.The noted bends on the core 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 the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the left lower extremities.A h-t supra core 35 guide wire was noted to unravel at the joint during use.The wire was not separated completely only at the coils and stretched.The device was removed.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• 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
• MDR Report Key: 12085209
• Report Number: 2024168-2021-05531
• Device Sequence Number: 3348173
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: 02/28/2023
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 1030361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR