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

Model Number	1044592
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with moderate calcification and mild tortuosity.The hi-torque (ht) powerturn guidewire was advanced to the rca and a dragonfly opstar imaging catheter was used to image the rca.After obtaining the image, the catheter had resistance during removal from the guidewire so both devices were removed as a single unit.The guidewire was noted to have separated at the distal end and the radiopaque portion of the wire had been sheared off.Fluoroscopy confirmed nothing remained in the patient.There was no adverse patient effect 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.The additional device referenced in b5 & d10 is filed under separate medwatch report number.
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported difficult to remove was not able to be replicated in a testing environment.The reported material separation and material split, cut or torn was observed as stretched coils.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.Factors that may contribute to difficult to remove include, but are not limited to, inner diameter of the catheter, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the catheter or guide wire.In this case, it is likely that the challenging anatomy contributed to the reported difficulty removing the device as it was reported that the guide wire was used in a calcified lesion that led to the reported and observed damages to the guide wire.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: HI-TORQUE POWERTURN¿
• 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23481992
• Report Number: 2024168-2025-11389
• Device Sequence Number: 10330133
• Product Code: DQX
• UDI-Device Identifier: 08717648173936
• UDI-Public: (01)08717648173936(17)260930(10)4100761
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112957
• 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): 02/19/2026

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: 09/30/2026
• Device Model Number: 1044592
• Device Catalogue Number: 1044592
• Device Lot Number: 4100761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: DRAGONFLY OPSTAR¿ IMAGING CATHETER.
• Patient Sex: Unknown