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

Model Number	M004PMR96200
Medical Device Problem Codes	Kinked (1339); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at time of event: over 18 years old.(b)(4).Device evaluated by mfr: unit was received for analysis after decontamination (in appropriate packaging).Visual inspection showed a twist near the butt bond and a kink between electrode rings #1 and 2.Microscopic inspection showed a compromised seal at ring #1, resulting in an opening into the catheter.An electrical test was performed with an analysis cable and the device was within specifications for all measurements.The ablation was verified by using the maestro generator 4000 and the metriq pump and the device was found within specifications.No error codes were displayed.X-ray showed a bent center support at the distal tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 14aug2017.It was reported that noise occurred during ablation and the tip of the catheter was kinked.During an ablation procedure with an intellatip mifi oi ablation catheter, severe noise appeared on the potential 1-2 of the catheter and all the potential was unable to be seen.Moreover, the tip of the ablation catheter got strangely bent and it became difficult to cauterize further.The procedure was completed with the same device without issue.No patient complications occurred and there was no patient injury.However, device analysis revealed a compromised seal at ring #1, resulting in an opening into the catheter.

• Brand Name: INTELLANAV 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: 6813356
• Report Number: 2134265-2017-08641
• Device Sequence Number: 1736104
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: (01)08714729848684(17)20200416(10)0020531648
• Combination Product (Y/N): N
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2017

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: 04/16/2020
• Device Model Number: M004PMR96200
• Device Catalogue Number: PMR9620
• Device Lot Number: 0020531648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65