MAUDE Adverse Event Report: ABBOTT VASCULAR PRESSUREWIRE¿ X GUIDEWIRE; CATHETER TIP PRESSURE TRANSDUCER

Model Number X

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 10/11/2022

Event Type  Injury  

Event Description

It was reported the pressurewire x, wireless was used for spasm examination.The examination was performed without ergonovine.Although electrocardiogram changes were observed, there were no abnormalities in imaging and chest pain findings, so a coronary flow reserve examination was performed.The pwx calibrated and equalized normally.A <6f sheath was used.The device was inserted near the left anterior descending mid lesion (before the distal).The device was purged with saline with an injector to remove the contrast in the device.Before and after purging, ventricular fibrillation occurred.The patient went into cardiac arrest; cardiac massage was performed immediately to restore the heart rate, consciousness, and blood pressure.The system was completely removed, and the sheath was reinserted from the other side (left hand), coronary angiogram was performed, and the procedure was completed.The physician commented that when considering the device position, it is difficult to imagine wire irritation, so it is believed that there was a delayed spasm or air was drawn into the catheter while manipulating the y-connector after the pwx entered the patient.No additional information was provided.

Manufacturer Narrative

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 revealed no other similar complaints.In this case, there was no reported device malfunction associated with the pressurewire.The reported patient effects of embolism, serious arrhythmias, and congestive heart failure are listed in the pressurewire instruction for use as known potential complications which may be encountered during all catheterization procedures.Information from the field stated that the pressurewire was used with a guiding catheter smaller than 6f.The pressurewire instructions for use (ifu) directs the user to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.A definitive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The unexpected medical intervention appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.(b)(4).

• Brand Name: PRESSUREWIRE¿ X GUIDEWIRE
• Type of Device: CATHETER TIP PRESSURE TRANSDUCER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15670940
• MDR Text Key: 302395951
• Report Number: 2024168-2022-11042
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20510G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SHEATH SIZE:<6F
• Patient Outcome(s): Life Threatening; Required Intervention