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

Lot Number	2092761
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cardiomems heart failure (hf) system was deployed over an unspecified hi-torque (ht) steelcore 18 guide wire in the left pulmonary artery (pa).Upon removal of the ht steelcore guide wire, the cardiomems hf system got caught and was pulled into the pulmonary arch.The ht steelcore guide wire was able to be removed independently.A non-abbott pa catheter was used to re-advance [reposition] the cardiomems hf system.The cardiomems was pushed into the right pa ; not the desired implant site, where calibration was performed successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 appear to be related to operational context of the procedure.Factors that contribute to difficulty removing the guide wire include, but are not limited to, outer diameter of the guide wire, challenging anatomy, device support, buildup procedural contaminants, user technique, and/or damage to the guide wire.The device was used after expiration date.A review of the lot history record indicated an expiration date (use by date) of 08-31-2024 and the procedure date was (b)(6) 2025 approximately fourteen months post expiration.It should be noted in the instructions for use (ifu) for ht guide wires indicates use by date symbol, which is next to the expiration date.The ifu deviation would not have contributed to the reported difficulty.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.
Additional Manufacturer Narrative
The device was not returned for analysis.A corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.The production records for this product could not be reviewed and a similar complaint query could not be performed because the part number and lot number were not reported.Based on the information provided, the investigation determined that the reported issue appear to be related to operational context of the procedure.Factors that contribute to difficulty removing the guide wire include, but are not limited to, outer diameter of the guide wire, challenging anatomy, device support, buildup procedural contaminants, user technique, and/or damage to the guide wire.In this case, it was reported that while retracting the steelcore, it got caught on the sensor device and pulled the sensor into the pulmonary arch.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.D4: catalog # updated from 1003282 to unk.D4: lot # updated from 2092761 to unknown.D4: the udi is not known as the part and lot number were not 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: 23599988
• Report Number: 2024168-2025-11633
• Device Sequence Number: 15775542
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: (01)08717648013959(17)240831(10)2092761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K982876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/12/2025

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: 08/31/2024
• Device Lot Number: 2092761
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2022
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White