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

Catalog Number C12059

Device Problems Break (1069); Communication or Transmission Problem (2896)

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

Event Date 05/09/2023

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported event of signal calibration failure could not be confirmed due to device conditions.Functional testing and electrical testing could not be performed due to the guide wire separation.It was noted that the distal tube and microcables were separated from the distal end of the proximal tube; however, the separation was still held together by the corewire.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 signal calibration failure was likely due to the noted separation.It is likely the noted separation occurred due to mishandling during preparation.The noted separation would cause an open circuit which could lead to the reported difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed using the pressurewire x wireless device.Calibration and equalization were attempted, but were not successful.The pressure curve was not displayed.An unspecified error message was displayed.The device was turned off and restarted; however, the issue remained.The device was removed and replaced with another pressurewire x; however, the same occurred.The system was turned off and restarted, but the same issue occurred, and the device was unable to be equalized.The procedure was continued without use of a pressurewire.There was no adverse patient effect or clinically significant delay.Returned device analysis noted that the distal tube and microcables were separated from the proximal tube at the transition/junction/ the corewire was intact and exposed, with the hydrophilic retracted from the uncoated metal of the proximal tube.Additional follow up with the site indicated that it was unknown when the device damage occurred; however, there were no adverse patient effects.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: 17633833
• MDR Text Key: 322087654
• Report Number: 2024168-2023-09379
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 08/28/2023

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: 20926G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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