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

Model Number	1007710
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 inadvertent interaction with the cardiomems delivery system sensor resulted in the reported difficult to remove.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.
Event or Problem Description
It was reported that the procedure was to implant a cardiomems sensor in the left pulmonary artery.During retraction of the cardiomems delivery system the sensor interacted with the delivery system and / or steelcore guidewire causing the sensor to be pulled back into the proximal left pulmonary artery.The steelcore guidewire was repositioned, and the delivery system was backed out over the wire.Following this the interaction with the sensor resolved allowing the sensor to settle in an acceptable location in the left pulmonary artery.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE STEELCORE¿
• 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: 23356447
• Report Number: 2024168-2025-11185
• Device Sequence Number: 18383731
• Product Code: DQX
• UDI-Device Identifier: 08717648014123
• UDI-Public: (01)08717648014123(17)270531(10)5060661
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K982876
• 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
• Report Date (Section B): 10/22/2025

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: 1007710
• Device Catalogue Number: 1007710
• Device Lot Number: 5060661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOMEMS DELIVERY SYSTEM.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 87 KG