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); Difficult to Advance (2920)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It was reported that the pressurewire x wireless device was to be used in the left circumflex (lcx) lesion with severe calcification.It was noted a 5f diagnostic catheter was being used.There was vessel angulation prior to reaching the target lesion and it was difficult to manipulate the device due to the resistance with the angulation.The device was able to be advanced and rfr was measured.The device was then removed with resistance and the radiopaque part of the device separated.The 5fr diagnostic catheter was replaced with a 7f guiding catheter and pci was performed.The separated part of the device had moved to the distal lesion when the device was advanced.An unknown 1.5x10mm balloon was attempted, but could not cross due to the vessel angulation.A snare and drug coated balloon (dcb) were used to retrieve the separated portion.It was noted that a non-abbott guide wire had also become stuck.It is unknown how the procedure completed.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: medical device problem code 2017 device code - less than 6 fr guide catheter used.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported event of material separation could be confirmed.However, the reported event of difficulty in advancing and removing could not be replicated in a testing environment as it was based on operational circumstances.There was a kink on the male connector area.The corewire and distal tip coil were noted to be separated.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 issues.The reported event of material separation resulting in foreign body in patient, difficulty in advancing, and difficulty in removing was likely due to the circumstances of the procedure.Based on the information, it was likely that anatomical conditions or incautious removal caused inadvertent damage such as bend/kink on the distal tip.The damage likely compromised the integrity of the distal tip which likely resulted in a separation.The guiding catheter also likely contributed to the reported issue.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, the user used a 5f catheter which likely contributed to the reported difficulties.The unexpected medical intervention appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: health effect - clinical code 4582 removed, 2687 added.

Event Description

Subsequent to the initial report, the following information was provided: the device was then removed with resistance and the radiopaque part of the device separated and remains free floating in anatomy.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: 18726993
• MDR Text Key: 335703134
• Report Number: 2024168-2024-01923
• 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,Followup
• Report Date: 03/21/2024

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: 30912G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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
• Treatment: SHEATH: <6F.
• Patient Outcome(s): Required Intervention