MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Catalog Number	1009660
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported kinked core 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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported kinked core.Factors that may contribute to a kinked core during use include, but are not limited to, interaction with challenging anatomy, interaction with accessory devices, device support, or manipulation against resistance.In this case, return analysis of the guide wire noted polymer damage.The polymer was torn and folded over itself, suggesting the wire interacted with an accessory device or calcified anatomy.It is possible that the stent delivery system interacted with the guide wire during advancement, resulting in the noted polymer damage and reported core damage; however, based on the information provided, this cannot be confirmed.Additionally, it is unknown if any coating remained inside the patient.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca).The bmw guide wire was advanced.A stent was attempted to be advanced, but could not advance on gw.The guide wire was removed from the patient and a kink was noted 15 cm from the tip of the gw.Another bmw guidewire was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found the polymer coating was noted to be folded over itself in the nitinol core area.The polymer coating material in the folded over was noted to have multiple tears.As blue polymer coding is not visible in the patient it is unknown if any coating remained inside the patient.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 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: 18624558
• Report Number: 2024168-2024-01307
• Device Sequence Number: 17996274
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: 08717648014338
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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: 03/31/2025
• Device Catalogue Number: 1009660
• Device Lot Number: 3041171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: Other
• Patient Sex: Unknown