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

Model Number C12059

Device Problem Positioning Problem (3009)

Patient Problem Vascular Dissection (3160)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A dissection occurred while using a pressurewire x wireless when the device was being positioned past the lesion, which was located in the mid lad.Resistance was felt while advancing/moving the pressurewire.After passing the left main, it was not possible to move the wire further.The physician took a non-sjm wire, which was being used as a body wire to stabilize the artery, and pulled and moved more at the pressurewire until the pressurewire was able to be removed.The physician went back into the guiding catheter and controlled the artery with contrast.At this moment, the contrast media could not enter in the interspace of the heart, and no dissection was seen.Ffr measurement was performed, and the value was 0.86.When ffr was finished, the vessel was controlled with contrast again.The contrast was seen going out of the artery, and the contrast could enter the interspace.The patient also had pain.A stent was placed at the position of the dissection.After, the patient felt well, and the patient's blood pressure was stable.The dissection was confirmed by a non-sjm imaging product.The patient was discharged in stable condition.

Manufacturer Narrative

(b)(4).Product evaluation: the results of the investigation concluded that the tip coil of the radiopaque tip had been bent and stretched; the hydrophilic coated distal tube had been bent; the shaft and the transition area between the coated proximal tube and the male connector had been kinked and bent.The guidewire was returned intact.Although the exact cause of the reported event remains unknown, the guidewire damage is consistent with the reported positioning issue.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 a review of the device history record.The cause of the guidewire damage is consistent with forcible contact during use.The pressurewire 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 dissection or perforation of blood vessels.The pressurewire 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 instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during all catheterization procedures.

• 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: 6099719
• MDR Text Key: 59776610
• Report Number: 3008452825-2016-00160
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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: 5576152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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
• Patient Outcome(s): Required Intervention