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

Model Number C12058

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2015

Event Type  Injury  

Event Description

One measurement was able to be completed successfully.During a second measurement difficulty was experienced while advancing and the device broke while in the aorta.The detached portion of the device was retrieved and the procedure was aborted.The patient is in stable condition following the procedure.

Manufacturer Narrative

(b)(4).The results of the investigation concluded that a portion of the core wire was broken distal to the jacket.The tip coil was detached from the jacket, which exposed the intact portion of the core wire.The detached core wire and tip coil were not returned.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 device.The cause of the broken core wire and detached tip coil is consistent with damage to the device during use.The pressurewire instructions for use (ifu) states that torqueing the pressurewire against resistance or repeated attempts to cross a total vessel occlusion may damage and/or fracture the pressurewire.

Event Description

A pressurewire aeris was used to assess a distal lesion in the left anterior descending artery with plaque.Difficulty was experienced while advancing and the device broke while in the aorta.The detached portion of the device was retrieved without further consequence to the patient.

Manufacturer Narrative

(b)(4).

• 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 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4605193
• MDR Text Key: 15310130
• Report Number: 3008452825-2015-00011
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

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: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: C12058
• Device Lot Number: 4854877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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): Hospitalization; Required Intervention