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

Model Number C12058

Device Problems Entrapment of Device (1212); Positioning Problem (3009)

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

Event Date 04/14/2017

Event Type  Injury  

Event Description

Ffr measurement was attempted using a pressure wire aeris.The device was placed in a collateral vessel and got stuck inside.It was reported that the device was hard to manoeuver.There was resistance felt when advancing/ manipulating the pressure wire.A small balloon was used to dilate and catch the wire.The device was pulled hard and was withdrawn from the patient.There were no consequences to the patient.A pressure wire x wireless was used without issue.

Manufacturer Narrative

The results of the investigation concluded that the tip coil of the radiopaque tip had been stretched at the proximal end, which exposed the corewire.The corewire was 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 tip assembly.The shaft had been bent at multiple locations.The information for use (ifu) includes specific warnings related to torquing or excessive manipulation of the guidewire which may result in damage or fracture of the guidewire.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.Although the exact cause of the reported event remains unknown, the guidewire damage is consistent with the reported positioning issue.The cause of the guidewire damage is consistent with forcible contact during use.The pressurewire x, wireless 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 x, wireless 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 x, wireless 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, 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: 6560436
• MDR Text Key: 74940411
• Report Number: 3008452825-2017-00101
• 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,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5813236
• Other Device ID Number: 05414734055772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• 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