MAUDE Adverse Event Report: ARDEN HILLS, MN INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

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

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the patient had an embolic event.An intellamap orion¿ mapping catheter was selected for use during an lvvt ablation procedure which took place on (b)(6) 2018.During the procedure, activated clotting times (acts) were 248, 303, and 307 seconds.Mapping was performed in the left ventricle (lv) and moved around with the main area of interest in the lv apex.Irrigated ablation was also performed in the lv apex.It was noted that the orion was fully deployed while ¿parked.¿ following the procedure, the patient experienced a headache and blurred vision.An mri was negative.No intervention was required; the patient was maintained on aspirin (asa).Symptoms resolved on their own and the patient was fine.The cause of the embolic event was not determined.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer (Section G): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7641301
• MDR Text Key: 112441955
• Report Number: 2134265-2018-05555
• 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: K122461
• 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: 05/31/2018

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
• Device Catalogue Number: RC64S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/27/2018
• 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): Other
• Patient Age: 44 YR