MAUDE Adverse Event Report: ARDEN HILLS, MN UMBILICAL CABLE; CABLE, ELECTRODE

Model Number M004RAUMBILICAL20

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: 2134265-2017-12778.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 of the umbilical cable noted no anomalies.The umbilical cable was connected to the rhythmia gen1 gold system and error message 1201 did not appear.All electrodes on the orion catheter were working correctly in rhythmia.Tested mapping and it was good.No oily liquid was on the catheter or umbilical cord when disconnecting.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: 2134265-2017-12778.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.

• Brand Name: UMBILICAL CABLE
• Type of Device: CABLE, ELECTRODE
• 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: 7134090
• MDR Text Key: 95672261
• Report Number: 2134265-2017-12777
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• 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

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M004RAUMBILICAL20
• Device Catalogue Number: RAUMBILICAL2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1