MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSUREWIRE¿ X, WIRELESS, RX 175CM; WIRE, GUIDE, CATHETER

Model Number C12059

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Event Description

The pressurewire x, wireless was inserted into the patient via the radius puncture site using a 5fr cag catheter.Moderate angulation was noted.There was slight resistance when the pressurewire x, wireless was advanced into the stent.When torque motion was applied to cross the stent, the tip of the device fractured and moved distally.The fractured tip was collected using a coaxial catheter, a snare catheter and two wires.The procedure was completed without using another pressurewire x, wireless.There were no consequences to the patient.

Manufacturer Narrative

One pressurewire x wireless was returned for analysis.The reported event of the distal tip coil fracture and positioning issue was confirmed.The results of the investigation concluded that the radiopaque tip and distal corewire had been fractured and not returned, indicated there was a missing material from the distal corewire assembly.There was evidence of the tip coil proximal weld joint.The shaft had been bent at multiple locations.Additional analysis revealed that the guidewire was exposed to excessive torqueing and manipulation causing the fracture at the distal tip coil and the distal corewire.Torqueing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may damage and/or fracture the pressurewire, which is inconsistent with the instructions for use.Information from the field states that the pressurewire was used with a 5f guiding catheter.The pressurewire ifu, also directs the user 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.Although the exact cause of the reported positioning issue remains unknown, the guidewire damage and the usage of the incorrect catheter size are consistent with the reported positioning issue.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): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8168874
• MDR Text Key: 130476805
• Report Number: 3008452825-2018-00424
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• PMA/PMN Number: K180558
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6578890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention