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

Model Number M004RC64S0

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr: 2134265-2017-12777.It was reported that foreign matter was present.A rhythmia umbilical cable st and intellamap orion¿ were selected to be used in a procedure however it was noticed that when disconnecting the catheter from the umbilical cable a the connector was wet on one part with some oily liquid."it was not clear if this came from the catheter or from the cable." both the umbilical cable and orion were replaced to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: visual inspection shows no visible abnormalities.The electrical test was performed and the device passed the test.Magnetic sensor resistance testing revealed that both pairs are within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Same case as mdr: 2134265-2017-12777.It was reported that foreign matter was present.Arhythmia umbilical cable st and intellamap orion¿ were selected to be used in a procedure however it was noticed that when disconnecting the catheter from the umbilical cable a the connector was wet on one part with some oily liquid."it was not clear if this came from the catheter or from the cable." both the umbilical cable and orion were replaced to complete the procedure.No patient complications were reported.

• 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: 7134100
• MDR Text Key: 95667913
• Report Number: 2134265-2017-12778
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1