MAUDE Adverse Event Report: ABBOTT VASCULAR 014 HT WINN GUIDE WIRE

Model Number	1012475
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 to treat a chronically total occluded (cto), heavily calcified de novo lesion in the anterior tibial artery.A 014 ht winn guide wire was advanced however the tip of the guide wire separated.No attempt was made to retrieve the separated portion and the tip remains inside the vessel.The procedure was discontinued.There was no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the retuned guide wire and the reported tip separation was 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 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.A cine was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the snapshot image provided evidence confirming the ht winn 200t did separate but did not confirm how it separated.In the absence of cine films a probable cause could not be determined.The investigation was unable to determine a conclusive cause for the reported tip separation.Based on the reported information and cine review, it is possible that inadvertent mishandling, manipulation and/or torqueing of the guide wire against the anatomy during advancement caused the tip separate; however, this could not be confirmed.The noted stretched coils likely occurred during retraction of the guide wire.Additionally, the reported patient effect appears to be related to the operational context of the procedure as no attempts were made to remove the separated tip and remains in the patient anatomy.The noted teflon damage likely occurred during retraction and was likely caused by the torque device used in the procedure.The noted bends on the guide wire likely occurred during packing for return analysis.The noted bend on the core likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: 014 HT WINN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10887973
• Report Number: 2024168-2020-09826
• Device Sequence Number: 2799083
• Product Code: DQX
• UDI-Device Identifier: 08717648156908
• UDI-Public: 08717648156908
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K101648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2021

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: 01/31/2022
• Device Model Number: 1012475
• Device Catalogue Number: 1012475
• Device Lot Number: 0020671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 01/13/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/05/2021; 02/05/2021
• 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: Other