MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) BLAZER¿ OPEN-IRRIGATED; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M004EPT96200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.  (b)(4).

Event Description

It was reported that hypotension, vessel perforation, cardiac tamponade and pericardial effusion occurred.Vascular access was obtained via femoral vein and transseptal puncture with anticoagulation therapy using a zurpaz" steerable sheath.The target lesion was located at the left inferior pulmonary vein (lipv) and mitral isthmus.A blazer" open-irrigated was selected for ablation.Tracking of the blazer oi was conducted with the rhythmia mapping system, the physician noted issues with impedance tracking of the blazer" oi catheter.Ablation was delivered with 30w on the lipv and 40w on the mitral isthmus when it was noted that the patient's blood pressure dropped.Also, it was noted that the left superior pulmonary vein was perforated and with tamponade.Echocardiogram showed that there was pericardial effusion and pericardial puncture was performed but was unable to stabilize the patient's condition.The patient was referred to the heart center for surgery.The procedure was not completed due to this event.No further patient complications were reported and the patient status was ok and was discharged from the facility.

• Brand Name: BLAZER¿ OPEN-IRRIGATED
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6110330
• MDR Text Key: 60245323
• Report Number: 2134265-2016-10043
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M004EPT96200
• Device Catalogue Number: EPT9620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention