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

Model Number 87035

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

Patient Problem Thrombosis (2100)

Event Date 03/21/2019

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 thrombus occurred.During an ablation procedure for ventricular tachycardia (vt), an intellamap orion catheter was used to map the right ventricle (rv) through an non-boston scientific (bsc) steerable sheath.After completing mapping of the rv, the orion was removed from the body.It was then noticed that a small piece of what was thought to be myocardium was entrapped within the orion splines.The myocardium is believed to have been trabeculation that was entrapped in the orion when it was collapsed, and then it was biopsied by the sheath when the orion was pulled back into the sheath.No cardiac effusion occurred and that was confirmed with ultrasound.The orion functioned normally and was used to complete the case.The biopsied myocardium was sent for histology and the results indicated what was thought to be myocardium was actually thrombus.The patient had no adverse event related to this event.Activated clotting times (act) were maintained at a target of 300 seconds for the length of the procedure.The catheters in the body during the procedure were the intellamap orion in the rv, a non-bsc coronary sinus (cs) catheter, a non-bsc fixed curve quadripolar in the rv and a non-bsc fixed curve quadripolar in the his position.The orion or the non-bsc sheath were likely to have contributed to the thrombus.No resistance was felt maneuvering the catheters.

• 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: 8495667
• MDR Text Key: 141338679
• Report Number: 2134265-2019-03662
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2019

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: 11/02/2019
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0022883960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other