MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER PRIME HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 87120

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced a pericardial effusion.An ablation procedure was being performed for atrioventricular reciprocating tachycardia (avrt).After the electrophysiology (ep) study was performed and a left lateral pathway was found, the physician used a blazer prime htd to ablate the pathway.They did not have success and felt he couldn't reach far enough and withdraw the catheter to check the mechanism.On removal of the catheter, the physician showed that the deflector mechanisms of the blazer prime htd was not working.The catheter's deflection mechanism was faulty; it did not deflect.A new blazer open-irrigated catheter was inserted and the procedure continued.They continued the procedure and a block was achieved.The physician then noted that the patient's blood pressure (bp) had dropped and pulse rate increased.They performed a cardiac ultrasound and found a large pericardial effusion, which was drained.The patient was discharged to intensive care unit (icu) with a pericardial drain in place and was in the icu overnight.She was in hospital until the (b)(6) 2019, when she was discharged home.The pericardial effusion resolved and patient was in sinus rhythm.It was reported that they had no way of knowing at exactly what time the pericardial effusion started; but it wasn't there at the start of the procedure.There was also a dynamic xt catheter and two viking electrode catheters in the body at the time.It was unknown which catheter(s) caused or contributed to the adverse events.

Event Description

It was reported that the patient experienced a pericardial effusion.An ablation procedure was being performed for atrioventricular reciprocating tachycardia (avrt).After the electrophysiology (ep) study was performed and a left lateral pathway was found, the physician used a blazer prime htd to ablate the pathway.They did not have success and felt he couldn't reach far enough and withdraw the catheter to check the mechanism.On removal of the catheter, the physician showed that the deflector mechanisms of the blazer prime htd was not working.The catheter's deflection mechanism was faulty; it did not deflect.A new blazer open-irrigated catheter was inserted and the procedure continued.They continued the procedure and a block was achieved.The physician then noted that the patient's blood pressure (bp) had dropped and pulse rate increased.They performed a cardiac ultrasound and found a large pericardial effusion, which was drained.The patient was discharged to intensive care unit (icu) with a pericardial drain in place and was in the icu overnight.She was in hospital until the (b)(6)2019 , when she was discharged home.The pericardial effusion resolved and patient was in sinus rhythm.It was reported that they had no way of knowing at exactly what time the pericardial effusion started; but it wasn't there at the start of the procedure.There was also a dynamic xt catheter and two viking electrode catheters in the body at the time.It was unknown which catheter(s) caused or contributed to the adverse events.

Manufacturer Narrative

F.10.Device codes: corrected the device was returned for analysis.The device did not have visual defects.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.Both right and left curves failed to reach the specified area of the template, the device failed the dimensional test.Guide coil collapse was observed under x-ray within the handle next to the tension screw and under the handle strain relief.

• Brand Name: BLAZER PRIME HTD
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9363553
• MDR Text Key: 167666002
• Report Number: 2134265-2019-14345
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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: 05/16/2020
• Device Model Number: 87120
• Device Catalogue Number: 87120
• Device Lot Number: 0020657646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/07/2020
• Patient Sequence Number: 1
• Treatment: BLAZER OPEN-IRRIGATED; BLAZER OPEN-IRRIGATED; DYNAMIC XT; DYNAMIC XT; VIKING ELECTRODE CATHETER; VIKING ELECTRODE CATHETER; VIKING ELECTRODE CATHETER; VIKING ELECTRODE CATHETER; BLAZER OPEN-IRRIGATED; DYNAMIC XT; VIKING ELECTRODE CATHETER; VIKING ELECTRODE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention