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

Model Number C12008

Device Problem Device Handling Problem (3265)

Patient Problem Vascular Dissection (3160)

Event Date 11/04/2015

Event Type  Injury  

Event Description

The patient experienced an iatrogenic dissection of the left main coronary artery during a scheduled pci procedure.The procedure was resolved with two stents.The physician declared that the event is not related to the pressurewire certus.The patient was enrolled in a study; study id code is: (b)(4); the patient code is: (b)(6).

Manufacturer Narrative

(b)(4).Product evaluation: 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 certus instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during all catheterization procedures the pressurewire certus instructions for use (ifu) states that potential complications which may be encountered during all catheterization procedures include but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias or death.

• Brand Name: PRESSUREWIRE¿ CERTUS¿
• 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: 5869443
• MDR Text Key: 51875600
• Report Number: 3008452825-2016-00110
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK131452
• 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: 07/20/2016

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 Model Number: C12008
• Device Catalogue Number: C12008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2016
• 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): Other
• Patient Age: 58 YR
• Patient Weight: 95