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

Model Number	1001780J
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility medwatch report received that states: mdr report #: mw5111748.During pci (percutaneous coronary intervention) for an acute mi (myocardial infarction), the end of the guidewire caught on the stent leaving a portion of the guidewire remaining caught on the stent.0.014" guidewire.Fda safety report id # (b)(4).Additionally, the following information was received: it was reported that the procedure was to treat a lesion located in the right coronary artery.After the guide wire separated, a snare was advanced to the separated portion of wire and a small piece was able to be snared and removed; however, another small piece of wire was left embedded behind the implanted stent.The patient was transferred to another hospital for second opinion related to this incident.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Medwatch report #: mw5111748.
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 and subsequent treatment appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT 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 # 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: 15547142
• Report Number: 2024168-2022-10359
• Device Sequence Number: 13942597
• Product Code: DQX
• UDI-Device Identifier: 08717648025976
• UDI-Public: 08717648025976
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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: 04/30/2024
• Device Model Number: 1001780J
• Device Catalogue Number: 1001780J
• Device Lot Number: 2052371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown