MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013317J
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2020
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.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the moderately calcified, moderately tortuous left anterior descending coronary artery.During use, an unknown marker was found on a versaturn f guide wire.Unspecified devices were 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
Visual analysis was performed on the returned device.The component misassembled / extra marker was not 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.The investigation determined the cause for the reported unknown / extra marker is due to the solder used to manufacture the device, that was likely mistaken for an extra marker.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11083853
• Report Number: 2024168-2020-10963
• Device Sequence Number: 13632127
• Product Code: DQX
• UDI-Device Identifier: 08717648198472
• UDI-Public: 08717648198472
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 05/31/2022
• Device Model Number: 1013317J
• Device Catalogue Number: 1013317J
• Device Lot Number: 0060861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1