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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ventricular Fibrillation (2130)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: the results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.The pressurewire aeris 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.

Event Description

The following was published online in the journal circulation: cardiovascular interventions on 18 march 2014 (doi: 10.1161/circinterventions.113.000978.) and referenced in the international journal of cardiology in a letter to the editor on 5 october 2014 (doi: http://dx.Doi.Org/10.1016/j.Ijcard.2014.09.164, 0167-5273 2014 elsevier ireland ltd.): two hundred patients with stable chest pain underwent coronary angiography for clinical indications, and were included in the study based on results that included the presence of epicardial vessels of greater or equal to 2.25mm in diameter with greater than or equal to 30% by visual estimate.Ffr was performed with a pressurewire to assess all epicardial vessels or major branches of greater than or equal to 2.25mm in diameter, which had thrombolysis in myocardial infarction 3 flow, regardless of whether these other vessels had a stenosis of greater than or equal to 30% or not.In one patient, there was an episode of ventricular fibrillation during ffr assessment of the right coronary artery, and further measurement was aborted.No additional information was available.

• Brand Name: PRESSUREWIRE¿
• 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 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5104582
• MDR Text Key: 26782461
• Report Number: 3008452825-2015-00083
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 08/31/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• 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