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

Model Number	1011880J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified lesion in the heavily tortuous right coronary artery (rca).Prior to dilatation of the lesion with a balloon, the balance middleweight (bmw) elite guide wire was advanced to the small and tortuous vessel with a jr4 guiding catheter and a lot of torque was required.There was no resistance noted, just the tortuosity of the vessel.Once the bmw wire was placed, it was noted that the tip had separated.The tip remains in the patient and there was no reported treatment.The patient is reportedly fine.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.Based on the information provided, the investigation was unable to determine a conclusive cause for the reported separation.In this case, the manipulation through the tortuosity and tight vessels/lesions required torqueing and/or pushing/pulling which may have produced stresses induced in the wire that exceeded the design of the wire.This indicates that the wire damage may have occurred due to operational circumstances of the procedure during insertion.This could not be confirmed because the device was not returned.The foreign body in patient was due to the case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10261376
• Report Number: 2024168-2020-05690
• Device Sequence Number: 3458472
• Product Code: DQX
• UDI-Device Identifier: 08717648144790
• UDI-Public: 08717648144790
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 10/31/2021
• Device Model Number: 1011880J
• Device Catalogue Number: 1011880J
• Device Lot Number: 9111461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JR4 GUIDING CATHETER
• Outcome Attributed to Adverse Event: Other