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

Catalog Number	1009660J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure in haemodynamics the abbott guide wire separated inside the artery of the patient.No additional information was provided.
Additional Manufacturer Narrative
B3: date of event estimated as 2/15/2023.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Additional Manufacturer Narrative
H6: health effect clinical code 2687 and 4614 were removed / codes 1528, 4624 and 4582 were added.D09, h3: correction - 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.The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.It was reported that the guide wire interacted with the patient¿s anatomy during removal, resulting in the difficulty encountered during removal.Manipulation of the wire, during its interaction with the anatomy, likely contributed to the reported material separation.The separated portion of the wire was surgically removed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the initially filed reports, additional information was provided.It was reported the procedure was to treat a tortuous lesion in the right radial artery.During removal of the bmw universal guide wire, resistance was met with the anatomy due to a severe spasm and the guide wire separated.The separated portion of the guide wire was surgically removed.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• 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: 18855096
• Report Number: 2024168-2024-02878
• Device Sequence Number: 3338518
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: (01)08717648065866(17)250731(10)3081771
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: 07/31/2025
• Device Catalogue Number: 1009660J
• Device Lot Number: 3081771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown