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

Model Number X

Device Problems Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

Visual and functional analysis were performed on the returned device.The reported signal calibration failure 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 product investigation/complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported signal calibration failure was likely due to operational context.Return analysis noted multiple fibers on the proximal end of the contact members of the proximal male connector area.In this case, it is likely that the transmitter was removed from the wire during preparation and wiped down with a cloth (or the like), which resulted in the inability to connect the device.The fibers likely caused insufficient electrical contact surface or interference between the guidewire and pwx transmitter, and subsequently lead to the reported/observed signal calibration failure.Once the fibers were removed from the contact members the device was able to be successfully connected, as expected without error.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 that the pressurewire x - wireless device could not be calibrated.The device failed to connect to the system and the lighting pattern was solid yellow.The device was confirmed to be fully inserted.The system was shut down and restarted.However, the same issue persisted.Therefore, the device was not used in the patient and the procedure was completed with another device.There was no patient involvement and no clinically significant delay in the procedure.Device return analysis revealed that the pressurewire was then removed from the transmitter and there were multiple fibers observed on the proximal end of the proximal male connector area.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: 15723669
• MDR Text Key: 304013262
• Report Number: 2024168-2022-11214
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 10720G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2021
• 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