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

Catalog Number C12059

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported that the mid left anterior descending (mlad) artery was wired, and an unspecified balloon and stent were used to treat the vessel, while a pressurewire x wireless device was positioned in the diagonal artery.When going to remove the pressurewire device from the anatomy, it was noted that the device was trapped by the implanted stent.Intervention was attempted via two unspecified balloons that were advanced to the trapped device and positioned behind it, while the trapped device was attempted to be pulled free.This was unsuccessful, and the distal tip of the pressurewire, at the transducer, broke off and was pulled into the left circumflex (lcx), and the aorta, where it remains free floating in the patient.There was no adverse patient sequela, however a clinically significant delay in the procedure was reported.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier: against resistance.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulty to remove was not able to be confirmed with the returned device as it was based on circumstances of the procedure.The reported material separation 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 complaint history revealed no other similar complaints reported from this lot.It was reported that the mid left anterior descending (mlad) artery was wired, and an unspecified balloon and stent were used to treat the vessel, while a pressurewire x wireless device was positioned in the diagonal artery.When going to remove the pressurewire device from the anatomy, it was noted that the device was trapped by the implanted stent.The pressurewire instructions for use (ifu) warns: do not use the pressurewire x guidewire together with another guidewire, for so-called jailed wire technique, due to difficulty in guidewire withdrawal and possible guidewire entrapment.In this case, the entrapment of the pressurewire resulting in separation and subsequent patient effects appear to be the result of implanting the stent in the mid left anterior descending (mlad) artery trapping the pressurewire which was positioned in the diagonal artery.Based on the reported information and analysis of the returned pressurewire, the reported difficulties and subsequent patient effects appear to be related to use error.The entrapment of the pressurewire resulting in separation and subsequent patient effects appear to be the result of implanting the stent in the mid left anterior descending (mlad) artery trapping the pressurewire which was positioned in the diagonal artery.As a result the distal tip of the pressurewire, at the transducer, broke off during removal and was pulled into the left circumflex (lcx), and the aorta, where it remains free floating in the patient.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: 17722498
• MDR Text Key: 323108201
• Report Number: 2024168-2023-09882
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• 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,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C12059
• Device Lot Number: 30502G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2023
• 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 Outcome(s): Required Intervention