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

Model Number M004EPTR9620K20

Device Problem Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been returned 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 on high flow.An intellanav oi was selected for use.Prior to introduction into the patient, it was noticed that the ports for cool flow were not working on high flow.The device was exchanged for another of the same device; however a large kink in the tip and the turning mechanism was not working properly when the device was removed from its packet.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by mfr:unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The device does not have visual defects.The device was connected to the water pressure fixture to perform the irrigation flow rate.One of the ports was not fully flushing and only had water dribbling out, which indicates an obstruction.Upon further inspection there is a blockage of some material in one of the ports on the distal tip.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

It was reported that the cooling ports were not working on high flow.An intellanav oi was selected for use.Prior to introduction into the patient, it was noticed that the ports for cool flow were not working on high flow.The device was exchanged for another of the same device; however a large kink in the tip and the turning mechanism was not working properly when the device was removed from its packet.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.

• 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: 6132142
• MDR Text Key: 61030307
• Report Number: 2134265-2016-10817
• 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: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2017
• Device Model Number: M004EPTR9620K20
• Device Catalogue Number: EPTR9620K2
• Device Lot Number: 19330357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• 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