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

Catalog Number C12059

Device Problems Material Frayed (1262); Incorrect, Inadequate or Imprecise Result or Readings (1535); Deformation Due to Compressive Stress (2889)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of event estimated as 01/31/2024.

Event Description

It was reported that the pressurewire x, wireless device calibrated and equalized successfully.The device was to be used in the diagonal branch lesion.However, measurement was unstable.The tip of the device was noted to be wavy and frayed.Therefore, the device was removed and pressurewire x, wireless device was used to complete the procedure.The transmitter status light was steady green.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported pressure signal drift was not confirmed as the results of the functional testing were within the specifications for the pressurewire.The device was able to calibrate, equalize, and function as expected.The reported material frayed in the tip coil could not be confirmed.However, there was a stretch noted on the distal tip coil.The reported bend/kink/wavy in the tip coil was confirmed.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 was unable to determine a cause for the reported pressure signal drift.It may be possible that procedural contaminants/contrast on the pressure sensor membrane or a system issue occurred contributing to the reported signal drift; however, this could not be confirmed.The reported wavy material was likely due to the circumstances of the procedure.It is likely that challenging anatomical conditions or excessive force inadvertently damaged the tip coil (such as bend, kink, or stretch) resulting in the reported issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B3: date of event is estimated as (b)(6) 2024.

• 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: 18868526
• MDR Text Key: 337302299
• Report Number: 2024168-2024-03018
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/20/2024

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: 31023G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2023
• 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