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

Model Number 87047

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The device was returned in a slight left curve position.A sliver of material from the me1 (green) collar was lifted; the collar appeared to have been shaved.The sliver was attached securely on one end.Heavy deposit of dried saline on the distal end.Dried saline was also present in the luer, on ring 3 and on the tip.Continuity checks were performed manually using a multi-meter and breakout box.The thermocouple/magnetic sensor/ and resistor id resistances measured in spec and were typical.The measurements were repeated in the right and left curve configuration and again, all measurements were within specifications and typical.Lcr test was performed which confirmed that the magnetic sensor measured within specifications.The device tip was placed in 37c de-ionized water with the butt bond submerged and a metriq pump programmed to 30ml/min was attached to the device.De-ionized water was pumped through the device for approximately 30 minutes.The mini electrodes were cleaned with a foam brush tool and dried.Sem photos of the tip and each of the mini electrodes were taken.No adhesive or foreign material was noted on the mini electrodes.The device's lumen was leak tested using an isaac pressure decay test system.The lumen pressure decay was measured three times, starting with 107 psi, with re-seating of the tb seal between each test.Pressure decay values were 0.8581, 0.0685, 0.0637 psi.The distal end was measured, starting with 15 psi.Pressure decay values were of gross fail for each of the three tests.The following equipment configuration and settings were utilized during testing.Irrigation holes and mes sealed off with touhy bourst seal for the lumen test and fixture e181359-100 was used to seal the distal end for the distal tests.Device connected to isaac tester using coiled copper connection pipe and luer fitting.The device underwent pre-soak and post-soak hdx testing.Noise testing in pre-soak and post-soak conditions met current device specifications, where peak to peak values were less than 0.4 mv.However, pump related vibrational noise (low frequency) was observed most noticeably in all mini bipoles, up to approximately 0.25 mv in some cases.The reported system wide tracking loss was not confirmed during any of the ablation cycles tested.One d06 temperature error (not reported) was observed when initially connecting the device after soak/irrigate process.Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.All electrode resistances measured in spec and were typical.The measurements were repeated in the right and left curve configuration and again, all measurements were within specifications and typical.The leak test was repeated.The proximal and distal sections of the device were separated.The pressure decay starting at 15 psi for the proximal end measured 0.0093 psi and 0.0043 psi and for the distal end had three gross leak readings (later found to be due to cracked luer.) the handle was opened.The proximal shaft was cut proximal to the butt bond and the insulation sheath was removed.Most of the guide coil coating was damaged exposing the metal coils.Extensive damage to the magnetic sensor wire insulation was also present - a stretch of approximately 19.5 cm of damage sensor insulation was located at the distal end of the proximal shaft including the damage to the black insulation sleeve over the wires.

Event Description

Reportable based on device analysis completed on 31jun2019.It was reported that the system shut down during ablation.During a redo pulmonary vein isolation (pvi) procedure, while ablating with a intellanav mifi open-irrigated catheter the system shut down.The catheter was replaced and the signal station (sis) restarted.The procedure was completed successfully using the second catheter.There were no patient complications.Device analysis revealed a shaved mini electrode collar and gross leak readings due to a cracked luer.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8731364
• MDR Text Key: 149096887
• Report Number: 2134265-2019-07399
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 22950532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1