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

Model Number M004RC64S0

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

Patient Problems Stroke/CVA (1770); Loss of Vision (2139)

Event Date 11/19/2020

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

It was reported that following an ablation procedure with an intellamap orion catheter to treat atrial tachycardia (at), the patient experienced a cerebrovascular accident (cva).They experienced loss of an eye, maybe transient but they did not know at the time.The activated clotting time (act) was greater than 300 during procedure.The catheter irrigation flow rate was "2, 17, 30 as usual." irrigation was never interrupted or stopped during the procedure.No blood clot was seen during each introduction of the orion.They performed very few radiofrequency (rf) shots.The patient's blood pressure was very variable during the procedure and the physician thought that it could be the cause of clot "drop." it was possible the return in sinus rhythm could be explain that event.The patient was considered as "at risk".The procedure was completed and "all was perfect during the procedure." the patient was fine at the end of the case.It was noted that the orion was not "parked" in a certain area during ablation.The product is not expected to be returned for analysis.

• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 10969963
• MDR Text Key: 220417897
• Report Number: 2134265-2020-17174
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/08/2020

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 Model Number: M004RC64S0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention