MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEELCORE 18 LT GUIDE WIRE WITH MICROGLIDE COATING; PERIPHERAL VASCULAR GUIDEWIRE

Model Number	1007710-J
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The supera stent delivery system, referenced is filed under separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2021, a percutaneous intervention was performed on the left superficial femoral artery, heavily calcified lesion.A supera stent was successfully implanted.A second supera stent (s-60-040-120-p6, 0050461) was also deployed successfully.While removing the second supera delivery system however, resistance was met between the second supera delivery system and the steelcore guide wire (1007710-j, 0080761).The guide wire and supera delivery system were removed without further issues as a single unit.There was no adverse patient effect, no intervention or treatment required, and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficulty to remove was not tested based on device condition.There were additional noted damages to the core and the coils.Also, a noted corkscrew bend on the core of the wire.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.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that anatomical conditions (heavily calcified lesion) and the previously implanted stent contributed to a reduced clearance causing the resistance between the second supera delivery system and the steelcore guide wire; however, this could not be confirmed.The additional damages to the core and the coils are likely contributed to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE STEELCORE 18 LT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: PERIPHERAL VASCULAR GUIDEWIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11599679
• Report Number: 2024168-2021-02582
• Device Sequence Number: 14291854
• Product Code: DQX
• UDI-Device Identifier: 08717648049347
• UDI-Public: 08717648049347
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K982876
• 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,Followup
• Report Date (Section B): 05/03/2021

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: 07/31/2022
• Device Model Number: 1007710-J
• Device Catalogue Number: 1007710-J
• Device Lot Number: 0080761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED SUPERA STENT; 6 FRENCH SHEATH; SUPERA STENT DELIVERY SYSTEM
• Patient Age: 78 YR
• Patient Weight: 83