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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

Clinical study (b)(6).It was reported that during an ablation procedure, a cardiac effusion occurred.A non-boston scientific intracardiac echocardiography (ice) catheter was used along with a non-boston scientific deflectable coronary sinus (cs) catheter and a fixed curve quadripolar catheter in the high right atrium (hra) / superior vena cava (svc).Transeptal was performed with a non-boston scientific needle and sheath.The left atrium (la) was mapped with an intellamap orion catheter.An intellanav mifi oi asymmetric curve ablation catheter was then placed into the la for therapy delivery.After the 8th lesion of the left sided wide antral circumferential ablation (waca), an aortic (ao) pressure drop was documented and a pericardial effusion was diagnosed on intracardiac echocardiogram (ice).The intellanav catheter and the transeptal sheath were removed from the la and a pericardiocentesis was performed.The patient's pressure stabilized and pressures were monitored for over 30 minutes.Once the patient was stable, another transeptal (not as posterior as first) was performed and he procedure was completed without further complication.The event resolved the same day.At that time, the cause of the effusion was unknown.The physician attributed it to possibly the initial transeptal puncture and not the therapy delivery from the ablation catheter.

Event Description

Clinical study interrupt af.It was reported that during an ablation procedure, a cardiac effusion occurred.A non-boston scientific intracardiac echocardiography (ice) catheter was used along with a non-boston scientific deflectable coronary sinus (cs) catheter and a fixed curve quadripolar catheter in the high right atrium (hra) / superior vena cava (svc).Transeptal was performed with a non-boston scientific needle and sheath.The left atrium (la) was mapped with an intellamap orion catheter.An intellanav mifi oi asymmetric curve ablation catheter was then placed into the la for therapy delivery.After the 8th lesion of the left sided wide antral circumferential ablation (waca), an aortic (ao) pressure drop was documented and a pericardial effusion was diagnosed on intracardiac echocardiogram (ice).The intellanav catheter and the transeptal sheath were removed from the la and a pericardiocentesis was performed.The patient's pressure stabilized and pressures were monitored for over 30 minutes.Once the patient was stable, another transeptal (not as posterior as first) was performed and he procedure was completed without further complication.The event resolved the same day.At that time, the cause of the effusion was unknown.The physician attributed it to possibly the initial transeptal puncture and not the therapy delivery from the ablation catheter.It was further reported that eight lesions were ablated around the left pulmonary veins prior to the effusion.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

Clinical study interrupt af.It was reported that during an ablation procedure, a cardiac effusion occurred.Abbott medical (stj) ice was used along with a biosense webster deflectable cs catheter and a biosense webster fixed curve quadripolar catheter in the high right atrium (hra) / superior vena cava (svc).Transeptal was performed with a bayliss needle and a terumo nagare sheath.The left atrium (la) was mapped with an intellamap orion catheter.An intellanav mifi oi asymmetric curve ablation catheter was then placed into the la for therapy delivery.After the 8th lesion of the left sided wide antral circumferential ablation (waca), an aortic (ao) pressure drop was documented and an effusion was diagnosed on intracardiac echocardiogram (ice).The intellanav catheter and the transeptal sheath were removed from the la and a pericardiocentesis was performed.The patient's pressure stabilized and pressures were monitored for over 30 minutes.Once the patient was stable, another transeptal (not as posterior as first) was performed and he procedure was completed without further complication.At that time, the cause of the effusion was unknown.The physician attributed it to possibly the initial transeptal puncture and not the therapy delivery from the ablation catheter.It was further reported that eight lesions were delivered around the left pulmonary veins prior to the effusion.It was further reported that the patient was administered a intravenous (iv)/intramuscular (im) injection of solu-cortef medication.The patient also had a ultrasound/echocardiogram/tee/tte performed.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 11004023
• MDR Text Key: 221476610
• Report Number: 2134265-2020-17652
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938385
• UDI-Public: 08714729938385
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2022
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0025749119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 02/16/2021; 04/07/2022
• Supplement Dates FDA Received: 03/11/2021; 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ABBOTT MEDICAL (STJ) ICE CATHETER.; ABBOTT MEDICAL (STJ) ICE CATHETER.; ABBOTT MEDICAL (STJ) ICE CATHETER.; BAYLISS TRANSEPTAL NEEDLE.; BAYLISS TRANSEPTAL NEEDLE.; BAYLISS TRANSEPTAL NEEDLE.; BIOSENSE WEBSTER DEFLECTABLE CS CATHETER.; BIOSENSE WEBSTER DEFLECTABLE CS CATHETER.; BIOSENSE WEBSTER DEFLECTABLE CS CATHETER.; BIOSENSE WEBSTER FIXED CURVE QUADRIPOLAR CATHETER.; BIOSENSE WEBSTER FIXED CURVE QUADRIPOLAR CATHETER.; BIOSENSE WEBSTER FIXED CURVE QUADRIPOLAR CATHETER.; TERUMO NAGARE SHEATH.; TERUMO NAGARE SHEATH.; TERUMO NAGARE SHEATH.; ABBOTT MEDICAL (STJ) ICE CATHETER; BAYLISS TRANSEPTAL NEEDLE; BIOSENSE WEBSTER DEFLECTABLE CS CATHETER; BIOSENSE WEBSTER FIXED CURVE QUADRIPOLAR CATHETER; TERUMO NAGARE SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG