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

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

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 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
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6813356
• MDR Text Key: 83539798
• Report Number: 2134265-2017-08641
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: (01)08714729848684(17)20200416(10)0020531648
• Combination Product (y/n): N
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 65