MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT ELITE; WIRE, GUIDE, CATHETER

Model Number	1011880
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/02/2024
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.
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery (rca) with mild calcification, mild tortuosity and 80% stenosis.The balance middleweight (bmw) elite guide wire was advanced to the c2 curve of the rca but was unable to advance or withdraw due to resistance with the device itself.A non-abbott guide wire was then advanced and the bmw elite was going to be withdrawn but it was noted that the tip of the bmw elite had separated and was in the c2 curve of the artery.The remaining portion of the wire was withdrawn and a stent was implanted to embed the separated portion against the vessel wall.Angiography was performed and showed no thrombus or dissection and there was timi 3 flow.There were no adverse patient sequela.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.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment and patient effect appear to be related to operational circumstances.It was reported that the guide wire met resistance during advancement and removal (failure to advance / difficult to remove).Factors that may contribute to a resistance during advancement and removal 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.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported failure to advance or difficult to remove.Additionally, the guide wire was reported to have separated during use.It is possible that manipulation of the wire when resistance was encountered contributed to the material separation.The separated portion of the wire was embedded using a stent.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 ELITE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 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: 20916317
• Report Number: 2024168-2024-14640
• Device Sequence Number: 7778871
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: (01)08717648144783(17)260131(10)4021471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/30/2025

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: 01/31/2026
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 4021471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RUNTHROUGH GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown