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

Catalog Number C12059

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

Visual, functional, and electrical testing were performed on the returned device.The reported signal drift could not be confirmed due to device conditions.Functional testing was performed, and it revealed that the device was unable to equalize.Electrical testing revealed no anomalies with the wire.Bends/kinks and stretched coil were noted.There were also bunched and torn material at distal tube region which was likely related to circumstances of procedure.It is likely that there was an interaction between pressure wire and device accessory (ie.Introducer needle, catheter, or stent) during withdrawal which could cause the distal tube material got stuck resulting in the noted bunched and torn material.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 that would have contributed to this event.The investigation was unable to determine a cause for the reported signal drift.However, it is likely that the reported issue was related to the noted damages.It is likely that the noted damages caused an intermittent electrical issue which could cause the reported signal drift; 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 the pressure wire x was calibrated and equalized successfully.The pd pressure was unstable when the pressure guide wire was placed at the distal end of the blood vessel, and the pressure curve exceeded the upper limit of the screen.After replacing the pressure guide wire with a new one, the procedure was successfully completed.There was no adverse patient effect.Based on the return device analysis, the hydrophilic coating was noted to be bunched sporadically throughout the entire length of the distal tube.The hydrophilic coating was torn but still intact sporadically throughout the entire length of the distal tube.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, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17613702
• MDR Text Key: 321923051
• Report Number: 2024168-2023-09253
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/24/2023

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: 01/31/2024
• Device Catalogue Number: C12059
• Device Lot Number: 20201G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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