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

Model Number C12059

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product evaluation: the results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.The pressurewire x instructions for use (ifu) warns the user to observe all guidewire movements.Whenever the guidewire is moved or torqued, the tip movement should be examined under fluoroscopy.Never push, withdraw, or torque the guidewire if it meets resistance or without observing corresponding movement of the tip, otherwise vessel/ventricle trauma may occur.The pressurewire x instructions for use (ifu) warns the user that torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture the guidewire.

Event Description

Post stent implant, ffr was performed using a pressurewire x wireless.When the pressurewire was pulled back, the tip of the wire remained in the vessel.No resistance was felt when pulling back or advancing the pressurewire.However, the physician alleged that the wire was pulled back with a non-sjm guide catheter and that he was not sure if resistance would have been felt.The physician alleged that the wire had been pulled back and then re-advanced under a stent strut, and that there was a large chunk of calcium that created a problem for a number of stents and balloons.The tip of the wire was stented against the vessel wall.The patient is stable.

Manufacturer Narrative

(b)(4).

Event Description

Ffr measurement was performed using a pressurewire x wireless.The lesion was found to be significant.Once it was determined that the lesion would be treated, several balloons and stents were placed over the pressurewire.When the pressurewire was pulled back, the tip of the wire remained in the vessel.No resistance was felt when pulling back or advancing the pressurewire.However, the physician alleged that the wire was pulled back with a non-sjm guide catheter and that he was not sure if resistance would have been felt.The physician alleged that the wire had been pulled back and then re-advanced under a stent strut, and that there was a large chunk of calcium that created a problem for a number of stents and balloons.The tip of the wire was stented against the vessel wall.The patient is stable.

• 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: 6095868
• MDR Text Key: 59720535
• Report Number: 3008452825-2016-00159
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 5583697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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
• Treatment: GUIDELINER GUIDE CATHETER
• Patient Outcome(s): Required Intervention