MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Cardiac Perforation (2513)

Event Date 12/13/2018

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 a cardiac perforation occurred.An intellanav oi ablation catheter, an intellamap orion mapping catheter, and another manufacturer's short sheath were selected for use during a premature ventricular contraction (pvc) ablation procedure in the right ventricular outflow tract (rvot).A map of the rvot was created.After the target was specified, the orion was withdrawn and the intellanav oi was inserted.It was observed that the rhythmia mapping system did not visualize the intallanav oi; error 1313-2 was shown.Initial troubleshooting did not resolve the issue.The intellanav oi was then replaced and the replacement catheter was regularly visualized.The physician proceeded with the ablation.At the end of the procedure, after the catheter was withdrawn, sonography revealed a perforation of the heart muscle.Following pericardial drainage, regular blood pressure was observed and no further action was required.The cause of the perforation could not be determined.There was no allegation or indication that the catheter visualization issue caused or contributed to the perforation.The physician had not mentioned resistance during use of the catheters.The physician "had the feeling" in the very end of the procedure that "something could have been wrong." ablation had only been performed with the second intellanav oi.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 8232121
• MDR Text Key: 132548412
• Report Number: 2134265-2018-64946
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M004RC64S0
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• 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
• Treatment: ABLATION CATHETERS: BSC INTELLANAV OI; MAPPING SYSTEM: BSC RHYTHMIA; SHEATH: TERUMO (SHORT)
• Patient Outcome(s): Required Intervention