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	07/29/2025
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, the investigation determined that the reported issue appears to be related to operational context.In this case, during guide wire removal the cardiomems sensor migrated proximal.The physician used the guide wire and pulmonary catheter to move the sensor forward to a stable location.It is unclear what the mechanism of this interaction was, but the movement of the guide wire appears to be directly related to the movement of the sensor.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that during the procedure to treat the left pulmonary artery.A right heart catheter was inserted floowed by a pulmonary angiogram.A.018 steelcore guide wire was placed in the artery and the catheter removed.The cardiomems delivery catheter was advanced and deployed.The catheter was re-inserted and when attempting to remove the guide wire, the sensor migrated proximal.The guide wire and catheter were used to move the sensor forward to a stable location where it remained.There was 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: 22865012
• Report Number: 2024168-2025-08840
• Device Sequence Number: 15760680
• Product Code: DQX
• UDI-Device Identifier: 08717648014123
• UDI-Public: (01)08717648014123(17)251031(10)3110661
• 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): 08/21/2025

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: 10/31/2025
• Device Model Number: 1007710
• Device Catalogue Number: 1007710
• Device Lot Number: 3110661
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 DEVICE.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White