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

Model Number	1005203
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The herculink elite stent delivery system referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the 100% occluded ostial superior mesenteric artery (sma).The herculink elite stent delivery system was advanced over a long spartacore guide wire.No issues were noted during advancement with the guide wire, but difficulty was noted advancing the herculink elite due to the patient anatomy, so removal of the device was initiated; however, during removal, resistance was noted with the guide wire.The device was pulled and the herculink elite stent delivery separated at a location outside the patient anatomy.After removing the proximal device, the proximal guide wire was cut to remove the herculink elite separated segment.The procedure continued using the same cut guide wire.A second herculink elite was then implanted without issue.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported difficulty to remove was confirmed.Additionally, it was noted that the wire had bends and teflon damage.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported.It should be noted that per instructions for use (ifu), hi-torque guide wires,guide wires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage.Do not use damaged guide wires.Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.In this case, the reported ifu violation does not appear to have caused or contributed to the reported difficulty to remove; however, use of the guide wire after damage may result in patient harm.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 the reported difficulty to remove appears to be related to operation circumstances of the procedure and user error.In this case, it is likely that the stent delivery system (sds) became damaged with the challenging anatomy resulting in resistance and the difficulty to remove during retraction.The core was then cut, and the guide wire was reused to complete the procedure.The noted bends and teflon damage on the guide wire likely occurred during the cutting of the guide wire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE SPARTACORE 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: 13609412
• Report Number: 2024168-2022-02042
• Device Sequence Number: 1989149
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K963702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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 Model Number: 1005203
• Device Catalogue Number: 1005203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RX HERCULINK ELITE STENT SYSTEM
• Patient Age: 81 YR
• Patient Sex: Female