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

Model Number C12058

Device Problem Delamination (2904)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/16/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, ffr was performed in the rca using a pressurewire aeris.The lad was checked, and one proximal and one distal lesion were noted.The vessel was very calcified, and there was difficulty advancing the pressurewire to the lesion.When the device was pulled back to equalize, the pressurewire became stuck due to a vessel dissection or plaque.While trying to remove the device, the pressurewire separated at the sensor leaving a 3cm tip in the left main.Most of the pressurewire was pulled out of the patient, but not the sensor tip.A snare was attempted to be used to remove the tip, but the snare caused uncoiling.On (b)(6) 2015, during surgery for removal of the tip, the uncoiled tip of the device was removed from the patient.The patient also underwent 3 bypass grafts in the lad.The patient was stable with no further complications.A cardiac echo revealed that tip was no longer seen in the aorta and left main.The surgeon stated that all of the pressurewire was removed from the patient.

Manufacturer Narrative

(b)(4).Product evaluation: the results of this investigation are inconclusive because the device was not returned for evaluation.A review of the device history record confirmed the device met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the pressurewire and the cause for the reported event remains unknown.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 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.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.

Manufacturer Narrative

(b)(4).A cd of coronary angiographic images was received for this event on august 14, 2015.Information on the cd also indicated that the patient¿s date of birth was (b)(6) 1935 and that the patient was a male.

• 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: 4912577
• MDR Text Key: 6013502
• Report Number: 3008452825-2015-00051
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/18/2015

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: 4867079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR