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

Catalog Number C12059

Device Problems Material Separation (1562); Communication or Transmission Problem (2896)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the pressurewire x wireless could not be calibrated, even after several attempts.The pal lighting color pattern at the moment of the failure was blinking green.The procedure was successfully completed with a new pressurewire x.There was no patient involvement.The returned device analysis identified that sensor membrane was separated and not returned.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported signal calibration failure was unable to be confirmed due to the returned condition of the device (sensor chip damage/separation).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.The investigation was unable to determine a root cause for the reported signal calibration failure.The device was returned with the sensor chip assembly fractured resulting in a separation, which prevented further functional testing of the guidewire.The sensor chip separation could have caused or contributed to the reported signal calibration failure; however, the cause of the damage appears to be caused by use condition(s) or handling technique(s) employed prior to use or occurred from post-use handling or shipping conditions.The guidewire was able to pass all tests and check points during manufacturing, indicating that the chip was not damaged or separated during the manufacturing process.There were also kinks/bends noted to the proximal tube and corewire of the guidewire, which were determined to be unrelated to the reported issue and were likely caused by post-use handling or shipping conditions.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, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18145620
• MDR Text Key: 328241569
• Report Number: 2024168-2023-12766
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/19/2023

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 Expiration Date: 08/31/2023
• Device Catalogue Number: C12059
• Device Lot Number: 10921G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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
• Patient Age: 49 YR
• Patient Sex: Male