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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. HELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON TEMPORARY PACEMAKER ELECTRODE

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OSCOR INC. HELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON TEMPORARY PACEMAKER ELECTRODE Back to Search Results
Model Number H05RH110S
Device Problem Material Rupture
Event Date 12/26/2015
Event Type  Malfunction  
Manufacturer Narrative

The device was in use for treatment. One shrouded 5f helios temporary bipolar pacing lead was received with no other accessories. No visible blood was found on the device. The balloon was visually inspected and is completely split open longitudinally. The tip protector was missing and was not returned. The electrical values were tested with a multimeter and are within manufacturing specifications. The returned device analysis reveals one 5f helios temporary bipolar pacing lead within manufacturing specifications. Upon evaluation, the inflation port looked normal. However, the balloon was completely split open longitudinally. A review of the device history records for this lot identified no manufacturing rejects or anomalies. The helios temporary bipolar pacing lead passed all in-process and qa final inspection steps before shipping to the customer, including balloon, inflation/deflation and leak testing. Per procedure, both manufacturing and qa check the balloons 100% for anomalies such as visual defects, leakage, inflation (leaving the balloon inflated for one full minute) and deflation. The balloon is inflated with 0. 75 ml of air, submerged in a water bath and checked for any bubbles indicating a leak or hole. It is believed that this device may have been subjected to stresses beyond its capabilities during use in the field. The reason for return could not be confirmed. Maximum inflation capacity is 3/4 cc. The 3/4 cc plastic syringe is included for inflation of the balloon. Information as to the amount inflated into the device was requested but not provided and the syringe used to inflate the device was not returned for analysis. The instructions for use (ifu) informs the user of possible complications and warnings: although temporary cardiac pacing has proven to be a feasible emergency procedure, the physician should be aware that certain complications can occur when a temporary pacing lead is introduced, such as myocardial perforation, fibrillation, arrhythmia, pulmonary embolism, and thrombus formation. The balloon rupture, vessel perforation, intimal disruption, and embolism are potential complications in the use of a balloon temporary pacing lead. In addition, the ifu informs the user of testing balloon integrity before use.

 
Event Description

The customer reported that the lead was inserted into the patient's body and the balloon would not inflate. The physician took the lead out of the body and tried to inflate it again and nothing happened. After this attempt, upon trying to inflate the balloon it ruptured.

 
Manufacturer Narrative

New information revealed that the physician inflated the balloon with twice the amount of air required and as a result, the balloon ruptured. It is believed that the physician used more air to inflate the balloon because the balloon did not inflate on first attempt.

 
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Brand NameHELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON
Type of DeviceTEMPORARY PACEMAKER ELECTRODE
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1618
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1618
Manufacturer Contact
jan flegeau
3816 desoto blvd.
palm harbor , FL 34683-1618
7279372511
MDR Report Key5394482
Report Number1035166-2016-00005
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/01/2017
Device MODEL NumberH05RH110S
Device Catalogue NumberH05RH110S
Device LOT NumberC1-09040
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/04/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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