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

Model Number X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 03/07/2022

Event Type  Death  

Manufacturer Narrative

The death date was estimated as (b)(6) 2022.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.A definitive cause for the reported occlusion, vascular dissection, and death, and the relationship to the product, if any, cannot be determined.The unexpected medical intervention and surgical intervention appear to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was performed in the left anterior descending artery.The patient presented with non-st-elevation myocardial infarction.The pressurewire x wireless was being used to measure the resting full cycle ratio; however, when the device reached the beginning of the vessel a dissection in the left main was noted, which caused a vessel occlusion.Reanimation was performed and the patient was put on extracorporeal membrane oxygenation (ecmo).The patient was transferred to another hospital but died once there.It could not be confirmed if the pressurewire x caused or contributed to the dissection.No additional information was provided.

• 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: 15695971
• MDR Text Key: 302671203
• Report Number: 2024168-2022-11126
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/28/2022

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 Model Number: X
• Device Catalogue Number: C12059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: QUANTIEN
• Patient Outcome(s): Death