MAUDE Adverse Event Report: ST JUDE MED 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 08/28/2014

Event Type  malfunction  

Event Description

It was difficult to get the product out of the carousel.When the physician used the product, strange values was shown.When the pressure-wire was removed it was stretched in the proximal part.

Manufacturer Narrative

No evidence of external induced markings (like scratching), inherent weak spots (like inclusions) or flaws from the mfg 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 bending and rotational/torsional 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: GUDIEWIRE SENSOR
• Manufacturer (Section D): ST JUDE MED 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: 4196662
• MDR Text Key: 20324736
• Report Number: 8030904-2014-00018
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 10/08/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: C12058
• Device Lot Number: 4514669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Patient Outcome(s): Required Intervention