MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE EXTRA S'PORT GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22235MJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 reported from this lot.There were no issues 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 core separation appears to be related to operational circumstances of the procedure.It is likely that during the procedure, the core became kinked or damaged resulting in the reported separation during retraction.Additionally, the treatment appears to be related to the operational context of the procedure as a snare device was used to remove the separated section of the guide wire.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Medwatch report - the user facility report number was not provided.
Event or Problem Description
User facility medwatch report received that states "pulling the wire back from () position and identified the proximal fractured end of the wire which was in the rt subclavian - able to snare the end of the wire and remove it entirely." a new same wire was used to successfully continue the procedure.No additional information was provided.

• Brand Name: HI-TORQUE EXTRA S'PORT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11922901
• Report Number: 2024168-2021-04602
• Device Sequence Number: 19932387
• Product Code: DQX
• UDI-Device Identifier: 08717648079610
• UDI-Public: 08717648079610
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K950156
• 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
• Report Date (Section B): 06/02/2021

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: 10/31/2022
• Device Model Number: 22235MJ
• Device Catalogue Number: 22235MJ
• Device Lot Number: 0111861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/02/2021
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 83