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

Model Number X

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 issue.The investigation was unable to determine a cause for the reported difficult to advance, material deformation and difficult to remove.It may be possible that the pressurewire may have gotten caught on a stent strut that was not fully apposed to the vessel wall.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.

Event Description

It was reported this was a procedure to treat the moderately tortuous left anterior descending coronary artery and the right coronary artery.A pressurewire x, wireless device was inserted and resting full-cycle ratio (rfr) was successfully measured.Two stents were successfully implanted.The pressurewire was reinserted to measure fractional flow reserve (ffr).However, the device became caught on the strut of one of the implanted stents.While there was no reported damage to the non-abbott stent, the pressurewire x sustained damage to the tip which resulted in an loss of durability.The device was removed and replaced with another pressurewire x, wireless device.There were no adverse patient effects and no clinically significant delay in the procedure.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: 14142261
• MDR Text Key: 289511805
• Report Number: 2024168-2022-04191
• 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
• Report Date: 04/19/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 10911G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2021
• 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 Age: 61 YR
• Patient Sex: Male