MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV OI

Model Number M004EPTR9620K20

Device Problem Issue With Displayed Error Message (2967)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer - the distal end is twisted from approximately 22mm to 90mm from the tip.There is a gap in the insulation where the distal tip is joined to the proximal shaft.Electrical testing was performed and the device was found within specifications.Thermocouple testing revealed that the temperature was 23.0c and increased when the tip was grasped.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reportable based on analysis completed on 31oct2016.It was reported that a catheter error and noise occurred.Mapping was attempted with an intellamap orion¿, intermittent noisy signals and poor tracking of the catheter occurred.The cable was replaced with no result.The catheter was replaced with another intellamap orion¿ and the issue was resolved.Ablation was performed with an intellanav oi, during delivery of rf energy a catheter error was displayed on the rf ablation generator and ablation egm¿s more noisy than usual.Physician elected to replace the catheter with no resolution; the catheter errored again during rf delivery.Upon replacement of the cable the intellanav catheter could not be seen.Replacement with a third cable, catheter visualized and ¿catheter error¿ does not occur.No patient complications were reported however; returned device analysis revealed separation of the outer insulation layer.

• Brand Name: INTELLANAV OI
• Type of Device: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6118551
• MDR Text Key: 60643596
• Report Number: 2134265-2016-10420
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2016
• Device Model Number: M004EPTR9620K20
• Device Catalogue Number: EPTR9620K2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• 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