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 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported failure to equalize was unable to be confirmed due to the condition of the returned pressure wire.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 investigation was unable to determine a cause for the reported faulty pressure registration.It may be possible that procedural contaminants/contrast on the pressure sensor membrane or the noted bends/kinks contributed to the reported faulty pressure registration; however, this could not be confirmed.The separations were not reported and may have occurred during post-use handling/packaging for return.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

Event Description

It was reported that the pressurewire x, wireless device was calibrated successfully.After the device was turned on and inserted into the patient's anatomy, there was no pressure signal present and equalization could not be performed.Therefore, the device was removed from the patients anatomy, zeroed again, then re-inserted into the patient's anatomy, but there was no pressure signal present.Therefore, the device was removed and another pressurewire x, wireless device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.*the device return analysis revealed that the corewire, and microcable(s) of the the pressurewire x, wireless device were separated 84.5cm distal to the proximal end of the pressure wire which is in an area introduced inside the patient.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: 16799593
• MDR Text Key: 313865802
• Report Number: 2024168-2023-04259
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

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 Expiration Date: 05/31/2024
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20608G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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