MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	87049
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure was confirmed through investigation analysis.Visual inspection revealed that there is a missing adhesive section between the tip and shaft.There is also a scrape mark in the sheath material proximal to the missing adhesive.The damaged area is proximal to mini electrode 2 (me2) and the seal appears to be compromised.Continuity checks revealed no electrical opens or shorts and all electrode/ thermocouple/magnetic sensor resistances measured in spec and were typical.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.X-ray showed no obvious anomalies.The impedance measurement between me2 and the tip was below specifications.The mifi noise reported by the field is most likely due to a crack in the me2 collar allowing fluid ingress in the tip.
Event or Problem Description
Reportable based on device analysis completed on december 23 2019.It was reported that noise was observed on mifi channels.During an cavo-tricuspid isthmus ablation procedure, an intellanav mifi xp catheter was selected for use.Noise was observed on the mifi eletrograms.When a mifi channel was paced, the noise would clear up.When another channel was selected and paced, that noise would clear up and the previous channel would again become noisy.The noise was not resolved and the procedure was completed.No patient complications were reported and the patient's current condition is fine.However, device analysis revealed missing adhesive section between the tip and shaft.

• Brand Name: INTELLANAV MIFI XP
• 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: 9613051
• Report Number: 2134265-2020-00319
• Device Sequence Number: 11430216
• Product Code: OAD
• UDI-Device Identifier: 08714729885733
• UDI-Public: 08714729885733
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 01/31/2022
• Device Model Number: 87049
• Device Catalogue Number: 87049
• Device Lot Number: 0023280475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1