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 Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The device did not have any obvious visible defects.There was dried body fluid in the luer, inside the irrigation tubing between the luer and handle, on the handle, shaft and tip.Both the tip and shaft were heavily coated with body fluid.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.The device was connected to a metriq pump and was purged at 60 ml/min.Four of the six irrigation ports were clear and flowed freely.The other two ports were microscopically examined and were noted to be plugged with dried body fluid.The dried body fluid was removed and now all six irrigation ports flow freely.The pump was programmed to 30ml/min and the device was irrigated for 30 minutes without any errors or pump messages.
Event or Problem Description
Reportable based n device analysis completed on 13dec2019.It was reported that the catheter would not initiate standby flow.During an ablation procedure, the intellatip mifi open-irrigated catheter would not initiate standby flow after previously working with no issue.After clearing the resulting alarm and error message multiple times, standby flow would still not initiate.The catheter was removed from the patient, the catheter cable was disconnected, and the pump was replaced, but the issue persisted.The catheter was exchanged, which solved the issue.The procedure was completed successfully with no serious injury or adverse patient effects.Device analysis revealed two irrigation ports were occluded.

• 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: 9569113
• Report Number: 2134265-2020-00049
• Device Sequence Number: 13567576
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: 08714729848684
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: 09/09/2021
• Device Model Number: 86493
• Device Catalogue Number: 86493
• Device Lot Number: 0022623712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1