MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004PM96200
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer - device not returned therefore analysis of complaint device could not be performed. the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. the most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported the catheter was contaminated while opening the package.Prior to an ablation procedure to treat atrial fibrillation, the manufacturer representative was opening an intellatip mifi open-irrigated ablation catheter.The packaging ripped in his hand and he brushed the handle of the catheter.The device was not used; a different device was used to complete the procedure.There were no patient complications.

• Brand Name: INTELLATIP MIFI OPEN-IRRIGATED 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: 6980464
• Report Number: 2134265-2017-10422
• Device Sequence Number: 16174807
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: 08714729848684
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• 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
• Report Date (Section B): 10/04/2017

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: 06/12/2020
• Device Model Number: M004PM96200
• Device Catalogue Number: PM9620
• Device Lot Number: 0020763900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1