MAUDE Adverse Event Report: ABBOTT VASCULAR PRESSUREWIRE X, WIRELESS, RX 175CM; WIRE, GUIDE, CATHETER

Model Number C12059

Device Problems Difficult to Insert (1316); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/23/2021

Event Type  malfunction  

Event Description

During the procedure, the device was manipulated into the rca #3 lesion and resistance was felt.Torque could not be applied in the rca#2 and rotating did not work.The device was attempted to be removed, however just the radiopaque part of the device appeared in the cine image and a fracture was confirmed.The radiopaque part protruding from the side hole remained inside the catheter tip, and so a balloon catheter was advanced within the cag catheter, which was then dilatated in order to trap the fractured tip.The tip was removed along with the catheter and the balloon.The cag catheter was able to capture the images with no significant delay.No fragments remained inside the patient which was confirmed by cine image and the fractured tip outside the patient.The procedure was completed with no adverse patient consequences.

Manufacturer Narrative

One pressurewire x, wireless was returned for analysis.The results of the investigation concluded that the radiopaque tip and distal corewire had been fractured and were not returned, consistent with the reported event.There was evidence of the tip coil proximal weld joint.There were multiple bends throughout the guidewire.Information from the field stated that the pressurewire encountered significant resistance while being positioned and/or manipulated and that the pressurewire was used with a 5f guiding catheter.The pressurewire instructions for use (ifu) ppl2119173 ver.A, directs that the user should never push, withdraw, or torque the guidewire if it meets resistance or without observing corresponding movement of the tip¿the ifu also mentions to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire damage is consistent with damage during use.

• Brand Name: PRESSUREWIRE X, WIRELESS, RX 175CM
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 52 calle 3 b31 coyol free zone; alajuela 20102
• MDR Report Key: 11776463
• MDR Text Key: 252205822
• Report Number: 3009564766-2021-00006
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• PMA/PMN Number: K161171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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 Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 10106G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1