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

Model Number C12059

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

When the pressurewire x was advanced to the lad it got stuck and could not be moved despite multiple attempts to move.The pressurewire was removed with a retrieve balloon.When the pressurewire was removed from the patient the tip was found damaged; the tip was almost detached.Another pressurewire x was used to complete the procedure.

Manufacturer Narrative

The results of the investigation concluded that a portion of the tip coil had been stretched.The tip coil and the shaft had been bent at multiple locations.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.Although the exact cause of the reported event remains unknown, the guidewire damage is consistent with the reported positioning issue.The cause of the guidewire damage is consistent with forcible contact during use.The pressurewire x wireless instructions for use (ifu) states 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 wireless ifu states that torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may damage and/or fracture the guidewire.The pressurewire x wireless ifu states that the pressurewire¿ x guidewire is a delicate instrument and should be handled carefully.The pressurewire x wireless ifu states that if the pressurewire¿ x guidewire gets stuck or is damaged during the procedure, immediately disconnect the transmitter and replace the damaged guidewire, including the transmitter, with a new one.

• Brand Name: PRESSUREWIRE¿ X, WIRELESS, RX 175CM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL; 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; 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: 6393821
• MDR Text Key: 69555302
• Report Number: 3008452825-2017-00049
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/08/2017

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: 09/30/2018
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 5660693
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• 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