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

Model Number C12058

Device Problems Kinked (1339); Stretched (1601); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 04/30/2015

Event Type  Injury  

Event Description

The pressurewire aeris was used to perform an ffr measurement in the right coronary artery.The wire was disconnected from the transmitter and a stent was advanced over the pressurewire.Advancing the stent kinked the pressurewire.The stenting was performed, and the physician attempted to remove the pressurewire.The pressurewire became stuck and stretched in the distal portion.A coaxial balloon was advanced on the pressurewire to withdraw it from the patient.All devices were removed from the patient.The distal tip of the pressurewire remained stuck on the coaxial balloon.

Manufacturer Narrative

(b)(4).The results of the investigation concluded the tip coil had been detached from the distal end of the jacket, which exposed the core wire.The core wire had been detached.The detached tip coil segment was returned partially inserted in the distal end of a non-sjm catheter with the detached segment of the core wire attached to the distal end.The tip coil was removed from the distal end of the non-sjm catheter, which revealed the tip coil had been stretched and the coils elongated.The device met specifications prior to leaving sjm manufacturing facilities as supported by the device history record.The cause of the tip coil and core wire damage is consistent with forcible contact.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.

• 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
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442
• MDR Report Key: 4785300
• MDR Text Key: 5879810
• Report Number: 3008452825-2015-00032
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 4895661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2014
• 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): Required Intervention