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

Model Number C12008

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

The physician inserted pressurewire into lad for a ffr measurement.Per the account, "the wire was not acting right." they removed the wire and noted the tip was fractured.They obtained a new pressurewire and performed procedure without incident.It appears to be bent and partially fractured at the tip, but is still attached.It is not a complete fracture.It does not appear to be stretched out.It was retrieved in one piece.No problems were observed with pt related to fractured wire.The wire was pre-shaped by physician before introduction into vessel.The guide used was an ebu 3.5 launcher.

Manufacturer Narrative

No evidence of externally inducted 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 fracture initiated by fatigue due to bending movement and propagated due to the combination of bending and tensile force before finally it was broken due to ductile mode of fracture.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; po box 6350; uppsala SE-75-1 35 ; SW SE-751 35 ; 8161000
• MDR Report Key: 4206707
• MDR Text Key: 15818134
• Report Number: 8030904-2014-00016
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: C12008
• Device Lot Number: 4226292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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 Age: 43 YR