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

Catalog Number	1009661
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2023
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.D4: the udi is unknown due to the part/lot number was not provided.Attachment medwatch report #mw5119967na.
Event or Problem Description
Received medwatch mw5119967 which states: we then tried pull back the bmw wire but the wire radio-opaque segment/tip became wedged behind the struts of the stent that we had just deployed.However as we pulled the wire through the catheter, the tip of the wire broke loose behind the stent but did not embolize.No additional information was provided.
Event or Problem Description
Subsequent to the initial reported information, it was reported that the patient presented st elevation myocardial infarction (stemi) and the procedure was to treat an 80% eccentric focal disease of the mid left circumflex coronary artery at the bifurcation.The bmw guide wire was able to be maneuvered into the distal left circumflex across the mid circumflex lesion.The guide wire was retrieved via snare and a remaining portion was fixed to the vessel wall with a 2.75x22 mm stent.The procedure was extended due to this portion of the procedure and the patient with persistent hypotension etiology was unclear.The patient was transferred to the intensive care unit (icu) in stable condition.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.A query of the complaint handling system for the reported lot was performed and revealed no other incidents/complaints.The investigation determined the reported difficulties and subsequent treatments appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B5 - describe event or problem: updated.D4: lot number updated from unknown to 2040871.E1 - initial reporter updated.

• 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: 17671309
• Report Number: 2024168-2023-09565
• Device Sequence Number: 15004590
• Product Code: DQX
• UDI-Device Identifier: 08717648014345
• UDI-Public: 08717648014345
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 03/31/2024
• Device Catalogue Number: 1009661
• Device Lot Number: 2040871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 78 KG