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

Model Number C12058

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

The pressurewire was advanced across a lesion in the mid lad and a stent was placed after obtaining ffr values.A stent was placed previously in the proximal lad and upon removing the pressurewire, it became stuck in the proximal lad.Force was used to remove the wire and the radiopaque tip became separated from the wire and remained in the patient.The physician was unable to retrieve the tip and a stent was placed in proximal lad to cover the tip portion that remained.The patient was stable following the procedure with no adverse consequences.

Manufacturer Narrative

The product has not yet been returned.A review of the device history record confirmed that the device was manufactured according to sjm specification.There was no indication the reported event was due to a device malfunction or any deficiency with the instructions for use requiring corrective action.We will continue to closely monitor the performance of this product for any significant trends.

• 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 33; SW SE-751 33
• Manufacturer Contact: emil andreas ; palmbladsgatan 10; box 6350; uppsala SE-75-1 35 ; SW SE-751 35 ; 8161000
• MDR Report Key: 4040556
• MDR Text Key: 20109948
• Report Number: 8030904-2014-00010
• 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: 07/03/2014

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: 04/01/2016
• Device Model Number: C12058
• Device Lot Number: 4514652
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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 Age: 80 YR
• Patient Weight: 89