MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSUREWIRE¿ AERIS¿; TRANSDUCER, PRESSURE,CATHETER TIP

Model Number C12058

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

Patient Problem Vascular Dissection (3160)

Event Date 10/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

When the pressurewire aeris was being used with a balloon for pci, the portion of the device outside of the patient became kinked and fractured.When the wire was being manipulated back to the mid rca, it jumped forward and dissected the vessel.Additional stenting was needed to resolve the dissection.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record for the above-referenced product was unable to be reviewed since the batch number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.The pressurewire instructions for use (ifu) states that excessive manipulation of the pressurewire when the sensor element or pressurewire tip is located in sharp bend may cause damage or tip fracture.The pressurewire instructions for use (ifu) states that torqueing the pressurewire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture, which may lead to a portion of pressurewire separating from the tip.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¿ AERIS¿
• 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: 6153088
• MDR Text Key: 61696133
• Report Number: 3008452825-2016-00169
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131452
• 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,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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