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

Model Number X

Device Problem Failure to Advance (2524)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the pressure wire x wireless was unable to cross the lesion in the calcified right coronary artery.Acute thrombosis occurred during advancement of the pressure wire x wireless.The patient's blood pressure and heart rate decreased.Atropine 1mgiv and dopamine 20mgiv were given and the patient's blood pressure and heart rate recovered.The procedure was completed.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported failure to advance was not able to be confirmed as it was based on procedural circumstances.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 indication of a lot specific product quality issue.The investigation determined that the reported failure to advance was likely related to circumstances of the procedure.It is likely that the failure to advance was caused by challenging anatomical conditions which was described as calcified.Additionally, it is likely that the kinks/bends noted on the returned unit occurred while attempting to advance against resistance.The reported patient effects of hypotension and arrhythmias are listed in the pressurewire x guidewire instruction for use as known complications that may occur during all catheterization procedures.A conclusive cause for the reported patient effects of bradycardia, hypotension and thrombosis resulting in treatment with medications, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 13809881
• MDR Text Key: 287422235
• Report Number: 2024168-2022-02826
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 01218G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2020
• 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
• Patient Outcome(s): Required Intervention