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

Model Number X

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported that during device preparation the pressurewire x - wireless device distal tip was broken when performing the j shaping.Therefore, the device was not used in the patient and the procedure was completed with another pressurewire x, device.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

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.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported break was not confirmed.However, there were stretched coils which was likely the damage being reported.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 reported from this lot.The investigation determined that the stretched tip coils were likely related to circumstances of the procedure.It is likely that the pressurewire tip was damaged during preparation.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: 16030299
• MDR Text Key: 308472094
• Report Number: 2024168-2022-12989
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20718G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• 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