MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSURE WIRE AERIS G8; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number C12058

Device Problems Detachment Of Device Component (1104); Kinked (1339); Physical Resistance (2578)

Patient Problem Death (1802)

Event Date 03/18/2015

Event Type  Injury  

Event Description

A pressurewire aeris was prepared for use on a patient with diffused coronary artery disease (cad) of the left coronary artery.The device met resistance while attempting to cross the lesion and was pushed through after reshaping the tip of device twice.Once the device was distal to the lesion, a kink was noted in the wire and on the next fluoroscopy a 3cm portion of the distal tip of the device had detached from the device.This fragment moved further down the vessel and rested within the myocardium.The decision was made not to retrieve the fragment as the patient remained stable and required a coronary artery bypass graph(cabg) due to cad.Two days following the cagb, the patient expired due to complications of the bypass surgery.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Additional information: (b)(4).The results of this investigation confirmed the core wire and the tip coil of the guidewire had fractured.A review of the device history record confirmed the device met all sjm specifications at the time it was manufactured, prior to shipment.The cause for the fracture remains unknown.The pressurewire instructions for use (ifu) states that torquing the pressurewire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture, which may lead to a portion of pressurewire separating from the tip.

• Brand Name: PRESSURE WIRE AERIS G8
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4685462
• MDR Text Key: 5674493
• Report Number: 3008452825-2015-00020
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K131452
• 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: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: C12058
• Device Lot Number: 4775987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention