MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSUREWIRE¿ X, WIRELESS, RX 175CM; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number C12059

Device Problem Disconnection (1171)

Patient Problem Thrombus (2101)

Event Date 04/16/2018

Event Type  Injury  

Event Description

A pressure wire x, wireless could not be equalized and lost signal when advancing past the lesion.The light remained green but no signal was reaching the quantien.A second device was used and could not equalize due to a drift.In the 20 minutes while attempting to do the ffr the patient had a stent thrombosis.This complication required the patient to receive balloon angioplasty and be admitted to the hospital.The patient required a repeat angiogram.The patient is stable now after the physician treated.Patient's information (e.G.Age, weight, gender, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.Please reference 3008452825-2018-00141 for the second device.

Manufacturer Narrative

The reported event of signal loss and an event of extended procedure was confirmed.The results of the investigation confirmed the pressurewire was unable to calibrate due to open circuits located at the sensor chip area.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported signal loss is consistent with the open circuits.Based on the received condition of the device and the information provided, the cause of the open circuits remains unknown.The pressurewire aeris instructions for use (ifu) states that potential complications which may be encountered during all catheterization procedures include but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias or death.

• Brand Name: PRESSUREWIRE¿ X, WIRELESS, RX 175CM
• 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, costa rica 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, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7480854
• MDR Text Key: 107152268
• Report Number: 3008452825-2018-00132
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161171
• 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,Followup,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6073348
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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; Other; Required Intervention