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

Model Number	X
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported pressure signal drift was not able to be reproduced/confirmed, as the returned pressurewire and cabled transmitter were unable to be connected and calibrated with a quantien system.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.The investigation was unable to determine a cause for the reported pressure signal drift.It may be possible that the displacement noted between the distal tube from the proximal tube exposing the micro cables contributed to the pressure signal drift.The damage may have occurred during use while torquing/positioning/removing the pressurewire within the 70% stenosed, mildly tortuous, and mildly calcified lesion in the left anterior descending artery; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
Event or Problem Description
It was reported that the procedure was performed in the 70% stenosed, mildly tortuous, and mildly calcified lesion in the left anterior descending artery.The pressurewire x cabled was calibrated and equalized; however, the signal drift affected the data accuracy.The pal lighting color pattern at the moment of the failure was blinking green.The procedure was successfully completed with a new pressurewire.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device analysis identified that the proximal tube was broken 1mm distal to the sensor assembly exposing the microcables.No additional information was provided.

• Brand Name: PRESSUREWIRE¿ X GUIDEWIRE
• Common Device Name: 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: 15964606
• Report Number: 2024168-2022-12556
• Device Sequence Number: 20251006
• Product Code: DXO
• UDI-Device Identifier: 15415067025736
• UDI-Public: 05415067025739
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: X
• Device Catalogue Number: C12009
• Device Lot Number: 10630G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPTIS MOBILE.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 76 KG