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 11/20/2023

Event Type  malfunction  

Event Description

It was reported that physician had connection problem with the pressure wire x device.The procedure was completed successfully with a new pressurewire x.There was adverse patient effect and no clinically significant delay in the procedure.Based on the returned device analysis, the device was expired and used after expiration date.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: 2017 device code clarifier- use after expiration.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported communication or transmission problem was unable to be confirmed due to the condition of the returned unit.Functional testing could not be performed as the pressurewire corewire, and microcables were separated 39 cm distal to the proximal tip.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.Based on the reported information and analysis of the returned pressurewire, the reported connection issue appears to be due to operational context.It is likely that during use, damage to the microcables occurred due to a kink resulting in the reported communication problem.The noted separations likely occurred at the kink due to post-use handling/packaging the device for return.It was determined that the pressurewire was used after expiration of 4/30/2022.The procedure date was (b)(6) 2023; therefore, the device was used approximately 19 months after expiration.The pressurewire instructions 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 of the product is important for the sterility, efficacy, and performance of the device.In this case, it could not be determined if the reported event was a result of the product being used past the expiration date.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 that physician had connection problem with the pressure wire x device.The procedure was completed successfully with a new pressurewire x.There was adverse patient effect and no clinically significant delay in the procedure.Based on the returned device, the lot number was expired and used after expiration date.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): 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: 18581932
• MDR Text Key: 334189348
• Report Number: 2024168-2024-01109
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/22/2024

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: 04/30/2022
• Device Catalogue Number: C12059
• Device Lot Number: 00506G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2020
• 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