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 06/11/2014

Event Type  malfunction  

Event Description

The pressure-wire became stuck in the stent and the coil portion of the distal tip of the pressure-wire was found to be stretched.Another pressure-wire was used to successfully perform ffr measurement.According to the physician there was not any resistance or difficulty in delivering.

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 fracture was initiated on upper bend of the surface on typical grinding marks probably due to high rotational force and then propagate along the surface to the bottom of the fracture surface due to rotational force before it completely breaks by a small tensile force.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: 4005277
• MDR Text Key: 20779255
• Report Number: 8030904-2014-00012
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/25/2014

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: 01/31/2016
• Device Model Number: C12058
• Device Lot Number: 141484
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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