MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLATIP MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86493
Medical Device Problem Codes	Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection revealed a rust color under the proximal seal of ring 1 and under both edges of the electrode.There were dried body fluid found on the handle, main shaft and distal end.Dried saline found on the distal end and inside several irrigation ports.Electrical testing revealed all electrodes, sensor and thermocouple resistances measured within specification and were typical.The functional testing revealed an abnormal resistance was felt when actuating the steering mechanism.The lumen pressure decay was measured and were found to be below the maximum acceptable limit.The x-ray inspection showed no anomalies.The catheter was dissected and all the ring electrodes were removed.Only ring 1 had rust color under the electrode.
Event or Problem Description
Reportable based on device analysis completed on 26feb2020.It was reported that the catheter could not apply current.During an ablation procedure to treat atrial flutter in the heart a intellatip mifi open-irrigated catheter was selected for use.When energization was performed, the temperature was displayed as lo, and could not apply current, therefore the catheter was replaced and the ablation was successfully completed without patient complications.However, device analysis revealed the ring 1 proximal seal was partially separated from the electrode allowing fluid to enter into the distal end cavity.

• Brand Name: INTELLATIP MIFI OPEN-IRRIGATED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9873221
• Report Number: 2134265-2020-03753
• Device Sequence Number: 14180496
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: 08714729848684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S008
• 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): 03/24/2020

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: 12/12/2021
• Device Model Number: 86493
• Device Catalogue Number: 86493
• Device Lot Number: 0023080503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 71