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 Intimal Dissection (1333)

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

Event Description

The following information was published in the european heart journal advance access on 1 september 2014, (doi: 10.1093/eurheartj/ehu338), and referenced in the international journal of cardiology in a letter to the editor on 5 october 2014: the famous-nstemi study was done to evaluate the outcomes of fractional-flow reserve (ffr)-guided management versus angiography-guided care in nstemi patients.Each of the 350 patients in the study had a diagnosis of recent nstemi including an additional risk factor for coronary artery disease.They each also had a least one coronary artery stenosis greater or equal to 30%.It was concluded for each patient that the stenotic lesion was amenable to instrumentation with an sjm pressure wire, and ffr measurements were completed.Two patients experienced dissections that were attributed to the pressure wire device.No additional information was available.The second event is reported under mfr report number: 3008452825-2015-00081.

• 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: 5103838
• MDR Text Key: 26748413
• Report Number: 3008452825-2015-00079
• 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,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
• 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): Hospitalization