MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Hi-Torque Steelcore¿; Wire, Guide, Catheter

Model Number	1003282
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
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 the procedure was to implant a cardiomems sensor.The steelcore guide wire was advanced into the patient followed by the cardiomems delivery catheter over the wire.Prior to deployment of the sensor, an attempt was made to retract the guidewire into the delivery system however it was noted the wire would not retract.After manipulation, the wire was able to be completely removed and a new steelcore wire was advanced.The same issue then occurred with the second wire, with resistance encountered when attempting to retract the wire back into the delivery system.At that point, the physician¿s became concerned there may be an issue with the delivery system itself; therefore the decision was made to remove the entire system, including the wire that remained stuck within the delivery system.Increased resistance was encountered at the sheath site during removal.After additional manipulation, the delivery system was successfully removed through the sheath with the guidewire still stuck at the distal tip.The sensor appeared compromised, so a new delivery system was open and utilized.No issues were encountered with the second delivery system or new guide wire.The second sensor was successfully deployed without additional complications.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported the procedure was to implant a cardiomems sensor.The steelcore guide wire was advanced into the patient followed by the cardiomems delivery catheter over the wire.Prior to deployment of the sensor, an attempt was made to retract the guidewire into the delivery system however it was noted the wire would not retract.After manipulation, the wire was able to be completely removed and a new steelcore wire was advanced.The same issue then occurred with the second wire, with resistance encountered when attempting to retract the wire back into the delivery system.At that point, the physician¿s became concerned there may be an issue with the delivery system itself; therefore the decision was made to remove the entire system, including the wire that remained stuck within the delivery system.Increased resistance was encountered at the sheath site during removal.After additional manipulation, the delivery system was successfully removed through the sheath with the guidewire still stuck at the distal tip.The sensor appeared compromised, so a new delivery system was open and utilized.No issues were encountered with the second delivery system or new guide wire.The second sensor was successfully deployed without additional complications.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 returned for analysis.The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned device.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 level product quality issue.As there was no damage noted to the device during the inspection prior to use, it is likely that interaction with the anatomy/other devices and/or manipulation of the device resulted in the noted device damages (distal core kink, stretched coils, multiple distal core bends) thus resulting 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.

• 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 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 25410365
• Report Number: 2024168-2026-02288
• Device Sequence Number: 10751469
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: (01)08717648013959(17)271231(10)6011661
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup,Followup
• Report Date (Section B): 09/25/2026

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 Model Number: 1003282
• Device Catalogue Number: 1003282
• Device Lot Number: 6011661
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 07/16/2026; 09/21/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/21/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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 CATHETER
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 169 LB