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

Model Number X

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported faulty pressure registration was not able to be reproduced/confirmed.However; displacement of the sensor jacket was noted.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 faulty pressure registration as the returned unit was not able to reproduce the reported event.The returned device was functionally tested in a coronary artery simulator and functioned as expected without error.The sensor jacket appears to be displaced and appears to be incidental (likely after the reported issue) which may have occurred during use while torquing/positioning/removing the pressurewire within the heavily calcified and tortuous left anterior descending artery.Evidence of what appeared to be adhesive was visible on the distal tube, as well as an indentation on the distal tube from where the sensor jacket was originally placed/fixed during manufacturing further attributes the likelihood that the damage occurred during/after use.The results of the functional testing also met specifications, which further supports the displaced sensor jacket as well as the multiple kinks/bends noted did not contribute to the reported faulty pressure registration and were incidental.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 the procedure was performed in a heavily calcified and tortuous left anterior descending artery.Post percutaneous coronary intervention, the transmitter of the pressurewire x, wireless device was reconnected and calibrated.However, the device was unable to equalize.Therefore, the device was removed and replaced.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis identified a break in the sensor jacket.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: 14639830
• MDR Text Key: 295484133
• Report Number: 2024168-2022-06156
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/08/2022

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: 07/31/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 10819G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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