MAUDE Adverse Event Report: ST. JUDE MEDICAL SYSTEMS AB PRESSUREWIRE AERIS; GUIDEWIRE SENSOR

Model Number C12058

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2014

Event Type  malfunction  

Event Description

When taken out of pt post case the pressure-wire had stretched at the tip, the platinum tip "coil" had unravelled.The tip was intact and nothing was left in pt.There were no adverse consequences to the pt.

Manufacturer Narrative

No evidence of externally induced markings (like scratching), inherent weak spots (like inclusions) or flaws from the manufacturing process that could have contributed to the failure were found on the core wire.From the visual examination and analysis of sem images it is likely that the heavy rotational and bending force could have caused the failure.Fracture surface features indicate that the fracture would have occurred due to ductile nature.A review of the device history record confirmed that the device was manufactured according to sjm specification.

• Brand Name: PRESSUREWIRE AERIS
• Type of Device: GUIDEWIRE SENSOR
• Manufacturer (Section D): ST. JUDE MEDICAL SYSTEMS AB; palmbladsgatan 10; box -6350; uppsala SE-75 1 35; SW SE-751 35
• Manufacturer Contact: emil anderas ; palmbladsgatan 10; box 6350; uppsala SE-75-1 35 ; SW SE-751 35 ; 8161000
• MDR Report Key: 4005259
• MDR Text Key: 4708786
• Report Number: 8030904-2014-00011
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2016
• Device Model Number: C12058
• Device Lot Number: 4473827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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