MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number	1013753
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that it was a cardiomems procedure.When the cardiomems was being advanced over the hi-torque command 18 guidewire thru the right ventricle, the patient's heart rate dropped to ~25 beats per minute (bpm).It was suggested that the guidewire and/or delivery catheter perturbed the patient's right bundle branch and heart block occurred.Isuprel was given to increase heart rate but did not work.Cardiomems was advanced into the pulmonary artery and deployed successfully.An electrophysiologist came into the room and a temporary pacing wire was placed into the right ventricle, patient was then being paced at 70 bpm.Rather than re-floating the swan into the pulmonary artery past the pacing wire, cardiomems was successfully calibrated to the initial right heart cardiac (rhc) pressures from the pulmonary artery.Patient is stable and was sent to the intensive care unit over the weekend for monitoring due to the heart block instead of being outpatient and ended up receiving a permanent pacemaker.The patient was discharged from the hospital on (b)(6) 2022.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of bradycardia is listed in the hi-torque command 18 guide wire for pta instructions for use as a potential adverse event associated with use of this device.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• 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: 15267397
• Report Number: 2024168-2022-08984
• Device Sequence Number: 6576803
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• 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): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 1120861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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 SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 106 KG