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

Model Number	1001780J-HC
Medical Device Problem Codes	Break (1069); Material Separation (1562); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balance middleweight hydro guide wire became unwound [break with stretched coils] when it met resistance during advancement with 2 other guide wires inside the guiding catheter.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretched coils and material separation was confirmed.The reported difficult to advance could not be tested due to the device condition.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 determined the reported difficulties appear to be related to the operational context of the procedure.It was stated that the guide wire was advanced with two other guide wire within the guide catheter.It is likely that interaction between the wires contributed to the reported resistance during advancement.Additionally, it was reported that the wire¿s coils stretched, and core separated during use.In this case, it is likely that manipulation of the wire, when resistance was encountered, contributed to the stretched coils and separation.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.B5: describe event or problem: updated.D4: primary udi number was corrected from ((b)(4)).H6: medical device problem code 1069 was removed.
Event or Problem Description
Subsequent to the initially filed reports the device was returned and the tip was separated.The tip separation was the damage initially reported by the account.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT¿
• 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: 21426794
• Report Number: 2024168-2025-01948
• Device Sequence Number: 12682773
• Product Code: DQX
• UDI-Device Identifier: 08717648025983
• UDI-Public: (01)08717648025983(11)240201(17)260131(10)4020171
• 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,Followup
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 1001780J-HC
• Device Catalogue Number: 1001780J-HC
• Device Lot Number: 4020171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Patient Sex: Unknown