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); Material Twisted/Bent (2981)

Patient Problem Vascular Dissection (3160)

Event Date 04/01/2021

Event Type  Injury  

Event Description

During the procedure, the device bent and was unable to be controlled and then tore in two parts.When the device was being retrieved, a dissection occurred in the right coronary artery.Both parts of the device were removed with a guide extension catheter and the planned investigation was carried out.The patient is stable.

Manufacturer Narrative

One pressurewire x, wireless was returned for analysis.The results of the investigation concluded that there were multiple bends and kinks throughout the guidewire, and the radiopaque tip and distal corewire had been kinked and fractured, which is consistent with the reported event.There was evidence of the tip coil proximal weld joint.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.The cause of the reported dissection remains unknown.

• 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: 11720699
• MDR Text Key: 252205967
• Report Number: 3009564766-2021-00004
• 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
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 01109G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention