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

Model Number C12058

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The pressurewire aeris ii guidewire was returned to the sjm product surveillance laboratory for analysis.Visual inspection confirmed the core wire had been fractured 15 mm from the proximal end.The tip coil was detached from the guidewire and was grossly uncoiled.The distal 15 mm remained coiled; there was 15 mm of the core wire inside the tip coil.No other visual anomalies were noted.The results of the investigation confirmed that the core wire had been fractured and the tip coil had detached.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The device met specifications prior to leaving sjm manufacturing facilities as supported by the device history record.The cause of the 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.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.

Event Description

The pressurewire aeris was used in a tortuous lesion in the rca.It was reported that it felt like the wire became kinked when it was inserted for equalization.Equalization was successfully performed.Upon advancement, the pressurewire went toward the rv branch and became stuck in a very small branch.When the physician pulled the pressurewire, the tip coil became stretched.The physician pulled the wire more and the tip became detached.A snare catheter was used to retrieve the tip, but it was unsuccessful.The detached tip was removed surgically on the same day, and the patient is recovering.The physician reported that the condition of the patient's vessel could have contributed to the event.

• 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: 5127098
• MDR Text Key: 27442095
• Report Number: 3008452825-2015-00086
• 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
• Report Date: 09/10/2015

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: 03/31/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5056705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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): Hospitalization; Required Intervention