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

Catalog Number C12059

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/25/2023

Event Type  malfunction  

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported pressure registration issue was unable to be confirmed due to the returned condition of the device (break resulting in separation of the corewire, distal tube, and microcables) which prevented functional testing.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 cause for the reported failed pressure registration (faulty pressure registration) was unable to be conclusively determined.The returned device was unable to be functionally tested due to the returned condition (break resulting in separation of the corewire, distal tube, and microcables).Information from the field states that there was no report of any device separations/detachments having occurred during the procedure; further, had the separation been present during use, the failure would have resulted in complete signal loss, and would not have been able to perform the initial signal calibration which was also reported as having been successful.There were also kinks noted to the proximal tube and the corewire of the guidewire, which can cause pressure registration issues and subsequent guidewire damage.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 pressurewire was intended to be used with the optis integrated system in the left anterior descending coronary artery, and was successfully calibrated; however, when it was inserted in the patient vasculature, it could not be equalized.It was removed and a second pressurewire was attempted, but had the same issue.The pal lighting color pattern at the moment of the failure was steady green.Ivus was performed instead.There were no adverse patient consequences.Returned device analysis noted that the pressurewire x was separated at the distal tube, microcables and corewire.Additional follow up with the site indicated that there was no report of any device separations or detachments during the procedure.It was unknown when the device issues occurred; however, no patient injury was reported.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: 18663898
• MDR Text Key: 334885513
• Report Number: 2024168-2024-01558
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 30524G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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: 78 YR
• Patient Sex: Male