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

Model Number C12059

Device Problems Entrapment of Device (1212); Sticking (1597); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

Sent to manufacturing analysis.

Event Description

The pressurewire x, wireless was calibrated and equalized as usual by radial approach using a 5fr catheter.An initial ffr measurement in lad was performed normally.When advancing the device to lcx for another ffr measurement, the tip of the device got stuck in the plaque at lcx#11 with severe angulation and the tip coil part was stretched and damaged.The tip of the pressurewire x, wireless was released by moving the pressurewire x, wireless and catheter back and forth.The procedure was completed without using another pressurewire x, wireless.No patient consequences.It was confirmed by the physician that no fragment was left in the patient.Patient specific information of patient identifier, age or birthdate, gender, and weight are not available for this complaint.

Manufacturer Narrative

The reported event of the distal tip coil fractured and stretched was confirmed.The results of the investigation concluded that the distal tip coil had been stretched and fractured into two sections.The corewire had also been fractured into two sections at the distal tip.The combined length of the two corewire sections indicated there was no missing material from the distal corewire assembly.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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the distal tip coil fracture and stretch is consistent with damage during use.Information from the field states that the pressurewire was used with a 5f guiding catheter.The pressurewire instructions for use directs the user to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.The pressurewire 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 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 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.The pressurewire instructions for use (ifu) instructs to confirm the compatibility of pressurewire diameter with the interventional device before actual use.

• Brand Name: PRESSUREWIRE¿ X, WIRELESS, RX 175CM
• 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: 7343642
• MDR Text Key: 102573140
• Report Number: 3008452825-2018-00077
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161171
• 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,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6225174
• Other Device ID Number: 05415067025715
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2017
• 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): Required Intervention