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 07/31/2023

Event Type  malfunction  

Event Description

It was reported that during preparation of the pressurewire x - wireless device, calibration failed.The device was not recognized by the system and the transmitter light was blinking green.The device was not used in the patient and the procedure was completed with another unspecified device.There was no patient involvement and no clinically significant delay in the procedure.Device return analysis stated that the pressurewire x - wireless device was returned with the proximal tube and microcables were separated 4.2cm proximal to the proximal end of the distal tube.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 (proximal tube and microcable 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 determined the cause for the reported signal calibration failure was related to operational context.The device was returned with a separation of the proximal tube and microcable, which prevented further functional testing of the guidewire.The separation was likely caused by the observed guidewire kinks.While the kinks were due to either use conditions(s) or the handling technique(s) employed, the separation likely occurred after use and from post-use handling or return shipping conditions.The observed kinks likely caused the reported issue, as damage to the guidewire can affect the pressure signal performance.There was also stretching to the distal tip coil, which was determined to be unrelated to the reported event.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: 18319649
• MDR Text Key: 330393444
• Report Number: 2024168-2023-13953
• 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: 12/13/2023

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: 21025G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2022
• 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
• Treatment: ILLUMIEN OPTIS SYSTEM.