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

Model Number C12058

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

After an angioplasty procedure on the inter-ventricular artery, the pressurewire was used to evaluate the result of the procedure.The pressurewire tip was unraveled during the right coronary artery dilatation.A new pressurewire was used to finish the procedure.No patient complication was reported.

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 fracture were found on the core wire.From the visual examination and analysis of sem images, it is likely that the initial bending followed by rotational/torsional caused the failure.Fracture surface features indicate that the fracture occurred by ductile mechanism which is expected for this material.A review of the device history record confirmed that the device was manufactured according to sjm specification.Ifu text extracts: excessive manipulation when sensor element or tip of pressurewire is located in sharp bend may cause damage or tip fracture.Torquing pressurewire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture, which may lead to a portion of pressurewire separating from the tip.Never push, withdraw or torque pressurewire if it meets resistance.

• Brand Name: PRESSUREWIRE AERIS
• Type of Device: GUDIEWIRE SENSOR
• Manufacturer (Section D): ST. JUDE MEDICAL SYSTEMS AB; palmbladsgatan 10; box-6350; uppsala SE-75 135; SW SE-75135
• Manufacturer Contact: emil anderas ; palmbladsgatan 10; box 6350; uppsala SE-75-135 ; SW SE-75135 ; 8161000
• MDR Report Key: 3915232
• MDR Text Key: 4518722
• Report Number: 8030904-2014-00009
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• 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: 04/25/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: C12058
• Device Lot Number: 135897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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