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

Catalog Number C12059

Device Problems Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that during the procedure the pressurewire x wireless device was not recognized.There were no reported adverse patient effects and no clinically significant delays in the procedure.After the initial information was reported, it was noted that the device was expired.No additional information was provided.

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 communication or transmission problem.It may be possible that an insufficient electrical contact between the guidewire and pwx transmitter occurred.It may also be possible inadvertent damage due to mishandling occurred resulting in open circuit which caused the reported issue; however, without having the device to examine, this could not be confirmed.It should be noted that the pressurewire x wireless instruction for use (ifu) references the ¿use by¿ date symbol which is available on the product label to indicate the product expiration date.The expiration date for this device was 31 december 2022.The expiration date of the product is important for the sterility, efficacy, and performance of the device.It could not be determined if attempting to the expired product caused or contributed to the reported calibration issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2017 - use after expiration.

Event Description

Subsequent to the initially filed report, additional information was received that the procedure date was updated to (b)(6) 2022, therefore the device was not used past the expiration date.No additional information was provided.

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 communication or transmission problem.It may be possible that an insufficient electrical contact between the guidewire and pwx transmitter occurred.It may also be possible inadvertent damage due to mishandling occurred resulting in open circuit which caused the reported issue; however, without having the device to examine, 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.B3 - date of event updated.H6; medical device problem code 2017 removed.

• 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): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17932368
• MDR Text Key: 325629281
• Report Number: 2024168-2023-11314
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 11/02/2023

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: 12/31/2022
• Device Catalogue Number: C12059
• Device Lot Number: 10121G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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