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

Model Number X

Device Problems Battery Problem (2885); Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported battery problem was not confirmed.There were no issues noted on the transmitter component, and the battery voltage met the specification.Functional testing could not be performed due to the noted corrosion on the sensor chip assembly.The corrosion was likely due to liquid exposure during post-procedure handling.There was also a torn material noted on the distal tube, and the sensor chip assembly was also displaced from the distal tube.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 battery problem.It may be possible that a steady yellow light instead of a blinking yellow light was observed during the procedure which could lead to the signal calibration failure.A steady yellow light was likely caused by the torn distal tube which may cause inadvertent damage to the wire such open circuit or broken connection.Based on the received information, the cause of torn material and sensor chip assembly displacement could not be determined.It may be possible that there was an interaction between the pressurewire and hemostasis valve during insertion/withdrawal that could result in the noted torn material and sensor chip assembly displacement; however, this could not be confirmed as it was based on operational circumstances.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 to treat a lesion in the mildly calcified left anterior descending (lad) artery.The pressurewire x wireless device was connected to the quantien system and inserted into the hemostasis valve; however, there was no signal.The pal lighting color pattern was blinking yellow.The device was unable to be calibrated or equalized and was not used.The procedure was continued with a second same device.There was no adverse patient effect and no clinically significant delay.Returned device analysis noted that the distal tube was torn, the sensor jacket was displaced, and corrosion was noted on the sensor chip assembly, distal tip coil and transition between the proximal and distal tube.Additional follow up with the site indicated that the site was unaware of the device damage, and it is not known when the damage occurred.There was no difficulty noted during withdrawal and no adverse patient effect.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported flashing yellow light was not confirmed.The investigation was unable to determine a cause for the reported flashing yellow light.It may be possible that a steady yellow light instead of a blinking yellow light was observed during the procedure which could lead to the reported issue.A steady yellow light was likely caused by the torn distal tube which may cause inadvertent damage to the wire such as an open circuit or broken connection.Based on the received information, the cause of torn material and sensor chip assembly displacement could not be determined.It may be possible that there was an interaction between the pressurewire and hemostasis valve during insertion/withdrawal that could result in the noted torn material and sensor chip assembly displacement; however, this could not be confirmed as it was based on operational circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2885, - removed.

• 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 Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16997181
• MDR Text Key: 315926898
• Report Number: 2024168-2023-05541
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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: 03/31/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 10408G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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