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); Kinked (1339); Difficult To Position (1467)

Patient Problem Vascular Dissection (3160)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).

Event Description

There was difficulty in crossing the pressurewire x into the lesion.The distal tip became kinked in a "z" shape, and some force was applied to remove the wire.Another pressurewire x was used for ffr measurement.The device was removed easily, but a dissection was noted in the proximal portion of the rca.A longer stent was placed to cover the dissected part of the artery.The patient was stable.Reference mfr report number 3008452825-2017-00037.

Manufacturer Narrative

Product evaluation: the results of the investigation concluded that the tip coil of the radiopaque tip had been kinked and the hydrophilic coated distal tube had been bent, consistent with the reported event.The guidewire remained intact.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 instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during all catheterization procedures.The pressurewire instructions for use (ifu) states that 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 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.

Event Description

Reference mfr report number 3008452825-2017-00037.

• 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: 6372445
• MDR Text Key: 68814200
• Report Number: 3008452825-2017-00035
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/16/2017

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: 10/31/2018
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 5734896
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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