MAUDE Adverse Event Report: ABBOTT VASCULAR HT SUPRA CORE 35; GUIDE WIRE

Model Number	1002703-02
Medical Device Problem Codes	Break (1069); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
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 with no calcification, no tortuosity, and 50% stenosis in the external iliac artery.The middle of a.035 ht supra core guide wire felt like it uncoiled [unraveled] and a 5 fr catheter was not able to re-advance over the guide wire.Therefore, a wire cutter was used to cut the guide wire distal to the issue because the catheter could not be advanced over the damaged section of the guide wire and then a new wire could be exchanged inside the catheter without losing wire position across the lesion.Another supra core guide wire was used to successfully complete the procedure.There were no reported adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report, additional reported information indicates that the guide wire was cut only to allow the new catheter shape to advance and an additional guide wire to be placed and not to prevent patient injury from the damage guide wire.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The break (cut) was confirmed.Advancing the guide wire through a proxy catheter was not tested due to the stretched coils and the noted core separation, 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.The investigation determined for the reported difficulty advancing appears to be related to the case circumstances.It is likely that that the wire may have been damaged during the procedure or during the reinsertion process of the 5fr catheter resulting in coil damage that lead to the reported difficulty to advance.The additional therapy to cut the wire and perform an exchange was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B1: adverse event removed h2: serious injury changed to malfunction.

• Brand Name: HT SUPRA CORE 35
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10607881
• Report Number: 2024168-2020-08139
• Device Sequence Number: 14370000
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K980119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 0012361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention