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

Model Number	1010480-H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the right coronary artery (rca) posterior left ventricular branch.The pilot 50 guide wire was advanced into the rca and into the posterior branch.A 2.0 x 12 mm trek dilatation catheter was advanced into the rca, but was unable to cross to the lesion in the posterior branch and was removed without difficulty.A 6french non-abbott guide catheter extension was advanced into the rca for support and a 1.5 x 20 mm non-abbott dilatation catheter was advanced, but was unable to cross the target lesion.The dilatation catheter and guide catheter extension were pulled back into the guide catheter.The decision was made to stop the procedure and all devices were removed from the anatomy.No difficulty was noted during removal; however, at that time, it was noted that the guide wire had separated, with a portion of the pilot guide wire remaining in the anatomy.The separated segment remained in the posterior branch, with a portion seen in the proximal rca.The patient was then transferred for a surgical coronary artery bypass graft (cabg) procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is retained by hospital and not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device 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 similar incidents reported 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.The investigation determined the reported guide wire separation and treatments appear to be related to case circumstances of the procedure and patient disease state.In this case, based on the reported information, it is likely that the patients challenging anatomical conditions and manipulation of the guide wire likely caused the guide wire to bend or kink ultimately resulting in the core separation.The separated portion of the guide wire remained in the posterior branch, and the patient was sent for surgical coronary artery bypass graft (cabg) procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect - clinical code 4582 - removed.

• Brand Name: HI-TORQUE PILOT 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 # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13430812
• Report Number: 2024168-2022-01151
• Device Sequence Number: 13980828
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: 08717648073854
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• 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): 03/04/2022

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: 08/31/2023
• Device Model Number: 1010480-H
• Device Catalogue Number: 1010480-H
• Device Lot Number: 1091371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male