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

Model Number C12058

Device Problems Difficult or Delayed Positioning (1157); Difficult to Insert (1316); Material Separation (1562)

Patient Problem No Information (3190)

Event Date 01/30/2014

Event Type  No Answer Provided  

Event Description

A pressure-wire aeris was used to perform an ffr in mid lad.A dragonfly catheter, a stent and a balloon catheter was passed over the pressure-wire aeris.The dragonfly catheter was used over the pressure-wire aeris again for post stent oct examination.The dragonfly catheter went off the monorail and the dragonfly catheter and the pressure-wire were removed from the pt.A bmw guide wire was used instead but was unable to get passed the guide.The distal part of the pressure-wire aeris was noticed to have separated and was removed from the guide.The bmw guide wire and the dragonfly catheter were re-entered successfully.

Manufacturer Narrative

The product has yet not been returned.A review of the device history record of all the potential lots 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 SYSTEM 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: 3660300
• MDR Text Key: 15175712
• Report Number: 8030904-2014-00003
• 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: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C12058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other