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

Model Number X

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Separation (1562)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional pressurewire x device referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported calibration was successful with the two pressurewire x (pwx) wireless.However, equalization failed; the pressure signal dropped from time to time.The same issue occurred with the two pwx, during use.The transmitter light at the time of the issue is unknown.The distal tube for both pressurewires was separated from the transition tube, but still held together by the corewire.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.No additional information was provided.

Manufacturer Narrative

Visual analysis, functional testing, and electrical testing were performed on the returned device.The reported event of faulty pressure registration could not be confirmed due to device conditions.However, the reported material separation was confirmed.Functional testing was performed, but it failed to calibrate.An electrical test was performed which revealed that there was an open circuit on the proximal tube region.It was noted that the distal tube was separated from the transition tube, but still held together by the corewire.The investigation determined that the reported faulty pressure registration was likely due to the noted open circuit which could be caused by the noted separation on the distal tube.It is unknown what caused the separation.It may be possible that an excessive force was used during the insertion/withdrawal of the device, or there was an interaction between pressurewire with another device during the procedure which could lead to the noted separation; however, this could not be confirmed as it was based on operational circumstances.Based on the analysis and received information, the separation was still held together by the corewire, and there were no adverse patient effects.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: 17041741
• MDR Text Key: 316478450
• Report Number: 2024168-2023-05745
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 06/13/2023

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 Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 21010G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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