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

Model Number	1009666J
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the hi-torque (ht) balance middleweight (bmw) universal ii w/o mark 190cm j guide wire (gw) was used in the mildly calcified, mildly tortuous lesion in the right coronary artery (rca).The guide wire met resistance with an unspecified source while advancing to the lesion.The wire became separated in the distal part of the lesion and was observed on fluoroscopy.A snare device was advanced via the femoral route and used to remove part of the guide wire; however, a fragment of the wire remained in the vessel without compromising the flow.An increase in the use of antiplatelet medication was provided to the patient.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database 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.A conclusive cause for the reported difficulties cannot be determined; however, the subsequent patient effect and treatment appear to be related to the operational context of the procedure.It was reported that the guide wire met resistance from an unknown source during advancement.Factors that may contribute to difficulty during advancement include, but are not limited to, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, challenging anatomy, interaction with accessory devices, and/or damage to the guide wire.In this case, based on the reported information and because the device was not returned for analysis, a conclusive cause for the reported difficulty during advancement cannot be determined.Additionally, it was reported that the wire separated during use.It is possible that manipulation of device, when resistance was met, contributed to the reported material separation.A portion of the separated wire remains within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 21334676
• Report Number: 2024168-2025-01422
• Device Sequence Number: 14409602
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: (01)08717648118777(17)260228(10)4031171
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K152709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: 02/28/2026
• Device Model Number: 1009666J
• Device Catalogue Number: 1009666J
• Device Lot Number: 4031171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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
• Patient Sex: Unknown