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

Model Number C12058

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).One pressurewire aeris ii was returned to the sjm postmarket surveillance laboratory for analysis.Visual inspection revealed the tip coil had been detached from the distal end of the jacket, which exposed the core wire.The core wire had been fractured and measured 19mm from the distal end of the jacket, which indicated there was missing material from the distal tip assembly.The tip coil and distal portion of the core wire were not returned.There were multiple kinks noted throughout the coated proximal tube.No other visual anomalies were noted.The results of the investigation concluded the tip coil had been detached and the core wire had been fractured.The tip coil and distal portion of the core wire were not returned.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 during use.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.

Event Description

A pressurewire aeris was used for a lesion in the rca with moderate tortuosity.After the pressurewire was crossed into the lesion, the tip coil became trapped in a small branch and the tip became fractured.A stent was placed over the tip, and the tip was not removed from the patient.The ffr procedure was aborted.

• 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- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5212142
• MDR Text Key: 30809995
• Report Number: 3008452825-2015-00100
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/19/2015

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: 02/28/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5031251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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