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	M004PM9620K20
Medical Device Problem Codes	Signal Artifact/Noise (1036); Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis after decontamination; the upn and lot number match those provided by the customer.The returned device has a bend located approximately 16 mm from the distal tip, which is proximal to ring three.Each of the rings around the mini electrodes appears to be cracked.In addition to the crack, a section of the ring around mini electrode three appears to be missing.Continuity checks revealed no electrical opens or shorts; all electrode, thermistor, and sensor resistance measurements were within specification.The steering knob and tenstion control knob functioned properly in both lock and unlock positions.No abnormal resistenace was felt when actuating the steering mechanism.Ablation was verified using a maestro generator 4000 and metriq pump and the device was found to be within specification.X-ray revealed a bend in the center support.Tip motion was evaluated and the device passed both the right and left curve tests.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
Event or Problem Description
Reportable based on analysis completed march 07, 2018.It was reported an intellatip mifi¿ oi ablation catheter was selected for use.The catheter had a kinked tip and noise was observed on multiple mifi electrograms.The procedure was completed with another catheter and there were no patient complications.However, returned device analysis revealed a section of the ring around mini electrode three was missing.

• 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: 7380907
• Report Number: 2134265-2018-02643
• Device Sequence Number: 19267725
• Product Code: OAD
• UDI-Device Identifier: 08714729848691
• UDI-Public: 08714729848691
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 04/19/2020
• Device Model Number: M004PM9620K20
• Device Catalogue Number: PM9620K2
• Device Lot Number: 20548241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1