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

Model Number	1009666
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was to treat a moderately calcified, moderately tortuous, right coronary artery.The hi-torque balance middleweight universal ii guide wire (bmw) was advanced without issue into superior branch of right posterolateral artery(rpla) however, when retracting the wire and redirecting down the main rpla, resistance was felt.It is unknown why resistance was felt in the distal superior anatomy.During removal attempts, the guide wire tip unraveled and broke off in the superior branch of the rpla.The rca was dissected upon removal of guidewire.The guide wire tip remains in the anatomy.No attempts were made to retrieve the tip.A non-abbott guidewire was used to complete the rest of the intervention with pre-dilation, stent, and post-dilation.Upon inspection after removal, guide wire appeared frayed and intermediate coils were stretched out with tip missing.A stent was implanted to treat the dissection.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and dimensional, inspections were performed on the returned guide wire.The reported tip separation and stretched coils were confirmed.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.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 was unable to determine a conclusive cause for the reported difficulty to remove and tip separation.It is possible that during the procedure the guide wire tip became damaged resulting in the reported difficulty to remove.Manipulation against resistance ultimately resulted in the reported tip/shaping ribbon separation and corkscrewed appearance during retraction; however, this could not be confirmed.The noted stretched coils likely occurred during retraction.The reported patient effect of dissection is listed in the instructions for use as a known patient effect(s) of the procedure.Additionally, the treatment appears to be related to the operational context of the procedure as the guide wire tip remains in the anatomy and a stent was implanted to treat the dissection.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: user facility medwatch report# 1400670000-2021-8006.D4: corrected the lot number from 1041971 to 0121171.
Event or Problem Description
Subsequent to the initially filed report a user facility medwatch was received which reported: tip of wire unraveled during shaping before entering the body-happened on two wires.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12400456
• Report Number: 2024168-2021-07771
• Device Sequence Number: 5190621
• Product Code: DQX
• UDI-Device Identifier: 08717648118739
• UDI-Public: 08717648118739
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072460
• 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,Followup
• Report Date (Section B): 10/19/2021

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: 11/30/2022
• Device Model Number: 1009666
• Device Catalogue Number: 1009666
• Device Lot Number: 0121171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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