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

Catalog Number C12059

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

Device code 2017 clarifier: failure to follow steps / instructions (sheath size less than 6 french).Visual inspection and functional analysis were performed on the returned device.The reported signal loss issue was not able to be confirmed due to the returned condition of the device (distal tube tear resulting in microcable break).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 cause for the reported communication or transmission problem (signal loss).The device was unable to be functionally tested due to the distal tube tear resulting in a microcable break.It is likely that the damage was caused post-use or during shipping conditions.It could also be that the damage to the guidewire was a result of the undersized guide catheter being used; however, this could not be confirmed.There were kinks/bends noted to the proximal tube, the proximal male connector area, the corewire, and the distal tube of the guidewire.It could be that the bends occurred during use, which caused intermittent or lost connection; however, this could also not be confirmed.Information from the field stated that the pressurewire was used with a guiding catheter smaller than 6f.The pressurewire instructions for use (ifu) directs the user to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.In this case, it could not be determined if using a smaller sized guiding catheter caused or contributed to the reported difficulties.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 during the procedure, two pressurewire x, wireless devices (20915g1 and 20926g1) were calibrated and equalized normally.The devices were intended to be used in the left anterior descending artery (lad) lesion.It was noted a less than 6f sheath was used against instructions for use.The transmitter was detached from the first device (20915g1) and the device crossed the lesion.However, when the transmitter was reconnected to the device, there was no response on the sensor.The transmitter light showed steady yellow.Reconnection could not be achieved.Therefore, the device was removed from the patient, and the second pressurewire x, device (20926g1) was detached from the transmitter, the device crossed the lesion.However, the same issue occurred as the first used device.Therefore, the device was removed from the patient, and the procedure was completed with a non-abbott device.There were no adverse patient effects and no clinically significant delay in the procedure.Analysis of the returned device (lot 20915g1) found the distal tube was torn for a length of 4mm and the microcable was separated at the same location.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: 17501661
• MDR Text Key: 321064645
• Report Number: 2024168-2023-08639
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/10/2023

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: 20915G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG