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

Model Number M004PMR96200

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199); Cardiac Perforation (2513); Complete Heart Block (2627)

Event Date 08/23/2018

Event Type  Injury  

Event Description

Same case as mdr id# 2134265-2018-60914, 2134265-2018-60917, 2134265-2018-60918.It was reported that hypotension, third degree heart block and perforation occurred.During an ablation procedure for left atrial flutter, a polaris x, an intellamap orion, an intellanav mifi oi lrg curve and intellanav mifi oi std curve were selected for use.The physician mapped the left atrium using the orion mapping catheter while pacing from the coronary sinus (cs) catheter.He removed the orion from the left atrium and replaced it with an intellanav mifi oi lrg curve catheter.After coming on ablation for 3 seconds, the generator gave a d07 excessive temperature error.He changed ablation cables and inspected the catheter tip for evidence of char and did not see any.The real time temperature reading on the ablation generator was giving an internal temperature of 86 degrees.The physician did not reinsert the catheter into the body and replaced it with an intellanav mifi oi std curve ablation catheter and began to ablate.They were able to deliver radiofrequency (rf) without any errors and ablated.They did not notice any abnormal readings in regard to temperature, power and impedance.They ablated for roughly 2 minutes when the patient's blood pressure began to rapidly drop and the patient went into third degree heart block.Transesophageal echocardiography (tee) demonstrated a perforation and compressions were started.The procedure was stopped and resuscitation efforts were continued.The patient was then stable and was admitted to the hospital with the possibility of cardiothoracic (ct) surgery depending on how next few hours went.

Event Description

Same case as mdr id# 2134265-2018-60914, 2134265-2018-60917, and 2134265-2018-60918.It was reported that hypotension, third degree heart block and perforation occurred.During an ablation procedure for left atrial flutter, a polaris x, an intellamap orion, an intellanav mifi oi lrg curve and intellanav mifi oi std curve were selected for use.The physician mapped the left atrium using the orion mapping catheter while pacing from the coronary sinus (cs) catheter.He removed the orion from the left atrium and replaced it with an intellanav mifi oi lrg curve catheter.After coming on ablation for 3 seconds, the generator gave a d07 excessive temperature error.He changed ablation cables and inspected the catheter tip for evidence of char and did not see any.The real time temperature reading on the ablation generator was giving an internal temperature of 86 degrees.The physician did not reinsert the catheter into the body and replaced it with an intellanav mifi oi std curve ablation catheter and began to ablate.They were able to deliver radiofrequency (rf) without any errors and ablated.They did not notice any abnormal readings in regard to temperature, power and impedance.They ablated for roughly 2 minutes when the patient's blood pressure began to rapidly drop and the patient went into third degree heart block.Transesophageal echocardiography (tee) demonstrated a perforation and compressions were started.The procedure was stopped and resuscitation efforts were continued.The patient was then stable and was admitted to the hospital with the possibility of cardiothoracic (ct) surgery depending on how next few hours went.The device was returned for analysis.Visual inspection showed dried saline present on the tip, electrodes, handle, connector and leur.Dried body fluid was present on the handle.The device did not have visual defects.Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.All electrode/thermocouple/magnetic sensor 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 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.Tip motion was evaluated against the curve template; both right and left curve tests passed.The ablation was verified by using the maestro generator 4000 and the metriq pump and the device was found within specifications.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/20/2018 09:53 am ct.The report number is being corrected from: 2134265-2018-64570 to: 2134265-2018-60919.This report is follow-up # 1.

Manufacturer Narrative

Device codes: the problem code 1069 captures the reportable event of cutting wire broken.Additional mfr narrative: visual examination of the returned device revealed that the cutting wire was broken and blackened.There was no other issue noted.The complaint was consistent with the reported event of cutting wire broke.It is most likely that a peak of voltage could have caused the failures noted.Therefore, it was concluded that the investigation conclusion code of this event is cause traced to component failure since the failure was associated with expected or random component failure without any design or manufacturing issue.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/27/2018 01:30 pm ct.The report number is being corrected from: 3005099803-2018-62240 to: 2134265-2018-60919.

Event Description

It was reported to boston scientific corporation that a dreamtome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the cutting wire of the device broke off from the distal end of the catheter.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second dreamtome rx 44, using the same generator and active cord.There were no user injury nor patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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; dc a330,; saint paul MN 55112
• MDR Report Key: 7885066
• MDR Text Key: 120548188
• Report Number: 2134265-2018-60919
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2020
• Device Model Number: M004PMR96200
• Device Catalogue Number: 87047
• Device Lot Number: 0022235635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR