MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEELCORE 18 LT GUIDE WIRE (MDD)

Catalog Number	1007710
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was a cardiomems implant procedure.The catheter was flushed and the steelcore guide wire was advanced into the target vessel.The sheath and wire were flushed and wiped prior to advancing the fully prepped cardiomems delivery system.During advancement to the target lesion, it was noted that the delivery system was not advancing well over the steelcore guide wire to the target location in the correct manner.Therefore, the sensor and delivery system were removed as a unit.The pulmonary wedge catheter was reinserted and the steelcore guide wire would not pass through the hub of the pulmonary wedge catheter.A new steelcore guidewire and cardiomems delivery system were used to complete the procedure.The patient experienced hemoptysis due to the second steelcore guide wire but this resolved on its own without intervention.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.
Additional Manufacturer Narrative
H6: medical device problem code 1494 - indication for use.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.Reportedly, the guide wire was used in a cardiomems procedure.It should be noted that the hi-torque guide wires instructions for use (ifu) states: ¿all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).¿ in this case, it is unknown if the deviation contributed to the reported issue.The investigation was unable to determine a conclusive cause for the reported difficulty during advancement and removal of the cardiomems over the guide wire.Factors that may contribute to difficulty advancing or removing the guide wire from the cardiomems include, but are not limited to, inner diameter of the cardiomems, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the cardiomems or guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during advancement or removal.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9: device available for evaluation updated from ni to no.
Event or Problem Description
It was reported that the procedure was a cardiomems implant procedure.The catheter was flushed and the steelcore guide wire was advanced into the target vessel.The sheath and wire were flushed and wiped prior to advancing the fully prepped cardiomems delivery system.During advancement to the target lesion, it was noted that the delivery system was not advancing well over the steelcore guide wire to the target location in the correct manner.Therefore, the sensor and delivery system were removed as a unit.The pulmonary wedge catheter was reinserted and the steelcore guide wire would not pass through the hub of the pulmonary wedge catheter.A new steelcore guidewire and cardiomems delivery system were used to complete the procedure.The patient experienced hemoptysis due to the second steelcore guide wire but this resolved on its own without intervention.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE STEELCORE 18 LT GUIDE WIRE (MDD)
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18723021
• Report Number: 2024168-2024-01907
• Device Sequence Number: 6350294
• Product Code: DQX
• UDI-Device Identifier: 08717648014123
• UDI-Public: 08717648014123
• 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,Followup
• Report Date (Section B): 03/21/2024

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 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): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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: 12FR COOK SHEATH; CARDIOMEMS DELIVERY SYSTEM AND SENSOR
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 98 KG