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

Model Number	1001780-HC
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
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 left circumflex/marginal coronary arteries.The balance middleweight hydro guide wire was opened and flushed and shaped.Once the wire was advanced out of the guiding catheter into the anatomy, it was noted that the tip was unraveled and stretched, but remained in one piece (not broken or separated).The device was removed without issue and a non-abbott guide wire was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that the core, shaping ribbon and coils separated.The core and shaping ribbon were separated 1mm distal to the center solder.The distal coils were separated, unraveled and stretched for a length of 32cm.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stretched coils was able to be confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent interaction with the guiding catheter resulted in the reported/noted stretched coils.Further interaction/manipulation of the device resulted in the noted separated/unraveled distal coils and ultimately resulted in the noted core, shaping ribbon and coils separations.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 22470989
• Report Number: 2024168-2025-07098
• Device Sequence Number: 4272842
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(11)250307(17)270228(10)5030771
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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 Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 5030771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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