MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE ALL STAR GUIDE WIRES

Model Number	1001740
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous, 100% stenosed lesion in the right coronary artery (rca).A 3cm, 014 allstar guide wire (gw) was being removed from the anatomy, when resistance was met with an implanted stent, and the guide wire became jailed.The jailed portion of the guide wire separated from the remainder of the wire, and remains jailed within the implanted stent, in the patient anatomy.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
The device was not returned 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 incidents/complaints from this lot.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.The separated portion of the guide wire remains entrapped within the implanted stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE ALL STAR GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16975196
• Report Number: 2024168-2023-05428
• Device Sequence Number: 2317471
• Product Code: DQX
• UDI-Device Identifier: 08717648013812
• UDI-Public: 08717648013812
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K972142
• 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
• Report Date (Section B): 05/22/2023

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: 1001740
• Device Catalogue Number: 1001740
• Device Lot Number: 3010461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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