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

Model Number C12058

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/04/2015

Event Type  malfunction  

Event Description

Procedures: the patient was brought to the cardiac catheterization laboratory in the fasting state.The right wrist was prepped with chloraprep and draped in the usual sterile fashion and anesthetized using 1% lidocaine.Using the front wall technique in the standard fashion with a 0.021 radial needle, a 6 fr slender glidesheath introducer was inserted into the right radial artery and 2.5mg of verapamil and 100mcg of nitroglycerin was given intra-arterially.Heparin 3700 units was given intravenously.Coronary angiography was performed via the right radial artery using a fl3.5-5 fr, ima-5 fr catheters.Diagnostic catheter engagement was difficult with an ar mod-5 fr catheter.

• Brand Name: PRESSUREWIRE AERIS
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st paul, MN 55117
• MDR Report Key: 5337807
• MDR Text Key: 34760271
• Report Number: 5337807
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2015

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: Unknown
• Device Expiration Date: 02/01/2017
• Device Model Number: C12058
• Device Lot Number: 5029446
• Other Device ID Number: 19265
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/24/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 91 YR