MAUDE Adverse Event Report: ARDEN HILLS, MN INTELLANAV OI

Model Number M004EPTR96200

Device Problem Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the cooling ports were not working.An intellanav oi was selected for a atrial flutter redo.However it was noticed during preparation that the irrigation ports not flowing.The procedure was completed with another intellanav oi.

Manufacturer Narrative

Device evaluated by mfr: the returned device matched the upn and lot number provided by the customer.The device does not have any obvious visible defects; dried saline was in the luer and tubing.The device passed electrical and ablation tests on the bench.No issue was found with the irrigation ports.No errors of faults were displayed during ablation tests in the neutral, right or left curve positions.The field allegations could not be confirmed.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that the cooling ports were not working.An intellanav oi was selected for a atrial flutter redo.However it was noticed during preparation that the irrigation ports not flowing.The procedure was completed with another intellanav oi.

• Brand Name: INTELLANAV OI
• Type of Device: INTELLANAV OI
• Manufacturer (Section D): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• 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: 6833880
• MDR Text Key: 84117611
• Report Number: 2134265-2017-08654
• 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,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2020
• Device Model Number: M004EPTR96200
• Device Catalogue Number: EPTR9620
• Device Lot Number: 0020219318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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