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

Model Number	1009660
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the distal right coronary artery (drca).A 190cm hi-torque balanced middle weight (bmw) universal guide wire (gw) was advanced without issue and a non-abbott balloon was used without issue.During removal of the bmw gw from the anatomy, the gw tip became stuck with the non-abbott balloon and separated from the rest of the wire inside the drca.The patient was transferred to a different hospital to attempt to snare the gw out of the anatomy, however the separated tip was not able to be removed and remained free floating in the drca.The patient is currently in the hospital in stable condition but will be undergoing surgery to remove the remaining tip of the guide wire.As of 05/17/2023, the patient has not undergone surgery for the removal of the separated portion in the anatomy.The patient remains stable.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficult to remove could not be tested due to the device condition.The reported material 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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment appears to be related to operational context.Factors that may contribute to difficulty removing the balloon dilatation catheter over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the catheter or guide wire.In this case, it is possible that the guide wire or catheter became damaged during the procedure, contributing to reduced clearance between the devices.Reduced clearance possibly contributed to the encountered resistance during removal.Additionally, it is possible that manipulation of the device when resistance was encountered resulted in the reported material separation and the stretched coils noted during return analysis; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 17072674
• Report Number: 2024168-2023-05943
• Device Sequence Number: 17666009
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: 08717648014338
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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: 12/31/2024
• Device Model Number: 1009660
• Device Catalogue Number: 1009660
• Device Lot Number: 3011671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X8 (NC METRONIC) BALLOON.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown