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

Model Number CVD0063

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

Patient Problem Intimal Dissection (1333)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).The pressurewire instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during all catheterization procedures.

Event Description

The following was published in the international journal of cardiology in a letter to the editor on 5 october 2014: "a preshaped pressure wire (aeris, st jude medical, st paul, mn, usa) was advanced to the distal rca with slight resistance encountered at the site of the most distal lesion (fig.1b) and hyperemia was induced with a peripheral infusion of adenosine at 140 g/kg/min.Ffr was 0.96 in the distal vessel, indicating no significant flow limitation.The wire was withdrawn to the catheter ostium where the absence of drift was confirmed in an otherwise uncomplicated procedure.Final check angiography revealed however, a distinct, asymptomatic, but persistent dissection flap at the site of the distal rca lesion (fig.1c inset) this was therefore stented with a 3.5 נ9 mm bare metal stent (integrity, medtronic, minneapolis, mn, usa) with a good final result (fig.1d).High-sensitivity troponin t peaked at 46 ng/l, left ventricular contractility remained normal, and the patient was discharged and remains well." (doi: (b)(4) /© 2014 elsevier ireland ltd.).

Event Description

Coronary angiography via the right radial artery revealed minor disease in all major coronary vessels except the right coronary artery, which appeared diffusely diseased.

• 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: 5100246
• MDR Text Key: 26617638
• Report Number: 3008452825-2015-00078
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• 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
• Device Model Number: CVD0063
• Device Catalogue Number: CVD0063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• 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
• Patient Age: 39 YR