MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV¿ MIFI XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004MR45000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported there was foreign material on the catheter.An intellanav mifi xp ablation catheter was removed from the packaging prior to an ablation procedure.When the catheter was removed from the packaging, there appeared to be a piece of sticky glue on the catheter itself.The glue would not have allowed the catheter to slide through the venous sheath.The device was not used within the patient; another catheter was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: visual inspection of the returned device revealed a 3cm length of clear adhesive tape wrapped around the main body tubing, approximately 75-79cm from the distal tip.The tape was torn on one end and was starting to peel away from the tubing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).
Event or Problem Description
It was reported there was foreign material on the catheter.An intellanav¿ mifi xp ablation catheter was removed from the packaging prior to an ablation procedure.When the catheter was removed from the packaging, there appeared to be a piece of sticky glue on the catheter itself.The glue would not have allowed the catheter to slide through the venous sheath.The device was not used within the patient; another catheter was used to complete the procedure.There were no patient complications.

• Brand Name: INTELLANAV¿ MIFI XP TEMPERATURE ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7047976
• Report Number: 2134265-2017-11256
• Device Sequence Number: 1260066
• Product Code: OAD
• UDI-Device Identifier: 08714729885719
• UDI-Public: 08714729885719
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2020
• Device Model Number: M004MR45000
• Device Catalogue Number: MR4500
• Device Lot Number: 0020937525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1