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

Catalog Number C12059

Device Problems Material Separation (1562); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that two pressurewire x, wireless devices (30313g1) were used in the distal right coronary (drca) artery.The first device was selected for use, however, after insertion a kink on the device was noted.The physician attempted to use a torque device to cross the lesion, however, the device broke (separated into two pieces) at the kinked area near the proximal end of the device.Therefore, the device was removed and the procedure continued with the second device.The second device was selected for use, however, after insertion a kink on the device was noted.Although a kink on the device was noted, the physician was able to complete the procedure with the second device.The device was removed without issue.The physician was not satisfied with the wire performance.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported kink and material separation was confirmed.The reported ease of handling (poor performance) could not be tested due to the condition of the returned device.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 indication of a lot specific product quality issue.Based on the reported information and analysis of the returned pressurewire, the reported difficulties appear to be related to circumstances of the procedure.The investigation determined the cause for the reported use of device problem (poor performance) and kink/bend was due to operational context.It is likely that during the attempt to cross the lesion, while pushing against resistance, the pressurewire guidewire became damage/kinked due to the resistance encountered or force applied which then affected the device¿s performance.Additionally, with continued manipulation, the pressurewire separated at the area of the kink.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B2 - outcomes attributed to ae updated.

• 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: 18149849
• MDR Text Key: 328296646
• Report Number: 2024168-2023-12767
• 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,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C12059
• Device Lot Number: 30313G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• 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