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

Model Number C12058

Device Problems Fracture (1260); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Product investigation: the results of the investigation concluded that the tip coil of the radiopaque tip had been fractured and separated from the distal of the jacket; the fractured tip coil was not returned.The corewire had been subsequently fractured.The distal portion of the fractured corewire was not returned.The distal corewire and shaft had been bent at multiple locations.Additional investigation revealed that the wire was exposed to excessive torque and manipulation and there is evidence of welding on the proximal joint between the coil and the 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 (ifu).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 forcible contact during use.The pressurewire aeris instructions for use (ifu) states that excessive manipulation of the pressurewire when the sensor element or pressurewire tip is located in sharp bend may cause damage or tip fracture.The pressurewire aeris instructions for use (ifu) states that torqueing 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.The pressurewire aeris instructions for use (ifu) states that the user should advance or withdraw the pressurewire slowly and never push, withdraw or torque the pressurewire if it meets resistance.

Event Description

The pressurewire aeris became caught in the stent strut.There was difficulty removing the device from the patient.

• 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, costa rica 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, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7025334
• MDR Text Key: 92752493
• Report Number: 3008452825-2017-00288
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5765083
• Other Device ID Number: 0541473405577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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): Other