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

Model Number	M004PM45000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that foreign material on the device was noted.An intellatip mifi¿ xp temperature ablation catheter was selected.When the device was unpacked from the handle part, silicone dust and some fragments were found at the side of the catheter.The device was not used and was exchanged.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.Unit was received for analysis after decontamination (in appropriate packaging).The returned device matches the upn and lot number provided by the customer.The device was received with a picture of the foreign material along with the message ¿caution foreign matter within the cushioning¿.The foreign material, which appears to be a section of a rubber band was in a bubble wrap envelope.The foreign material was taken out of the bubble wrap and placed in a sterilization pouch and was decontaminated with the catheter.Continuity checks revealed no electrical opens or shorts.All electrode/thermistor/sensor resistances measured in spec and were typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against the specified curve template/fixture.Both right and left curve tests passed.The ablation was verified by using the maestro generator 4000 (25064780), and the device was found within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be manufacturing related.Bsc id# (b)(4) / tw# (b)(4).
Event or Problem Description
It was reported that foreign material on the device was noted.An intellatip mifi¿ xp temperature ablation catheter was selected.When the device was unpacked from the handle part, silicone dust and some fragments were found at the side of the catheter.The device was not used and was exchanged.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: INTELLATIP 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: 6652955
• Report Number: 2134265-2017-06026
• Device Sequence Number: 11083997
• Product Code: OAD
• UDI-Device Identifier: 08714729848011
• UDI-Public: (01)08714729848011(17)20191115(10)19953758
• Combination Product (Y/N): N
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: 11/15/2019
• Device Model Number: M004PM45000
• Device Catalogue Number: PM4500
• Device Lot Number: 19953758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1