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 Infarction, Cerebral (1771)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it was indicated that the device would not be returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.(b)(4).

Event Description

It was reported that a cerebral infarction occurred.On (b)(6) 2017, during an ablation procedure for atrial tachycardia (at), an orion catheter was selected for use.Mapping was performed with the orion catheter and then ablation with a non-bsc ablation catheter occurred.The tachyrhythmia was once terminated, however, it occurred again "as a natural cause." therefore, mapping with the orion was again performed.The procedure was completed without problem after about 5 hours with that device.There was no issue with the orion catheter during the procedure.Eleven days after the procedure, on (b)(6) 2017, the patient experienced a cerebral infarction.The patient decided to take "a wait and see approach." the cause of the cerebral infarction was unknown, but "it took time to complete the procedure and thrombosis might have been caused.".

Manufacturer Narrative

Describe event or problem was updated.(b)(4).

Event Description

It was further reported that the cerebral infarction was temporary.The patient's condition was stable.

• 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: 6824493
• MDR Text Key: 83812133
• Report Number: 2134265-2017-08785
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K122461
• 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,Followup
• Report Date: 08/17/2017

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: 08/17/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 09/12/2017
• 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