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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 PACING LEAD

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OSCOR INC. HELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON TEMPORARY PACING LEAD Back to Search Results
Model Number H05RH110U
Device Problem Material Rupture
Event Date 04/01/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was in use for treatment. Inspection of the returned helios temporary pacing lead found extensive damage to the balloon at the distal end of device. The balloon material had torn along the entire length between the two balloon straps. The damaged balloon had a longitudinal split in balloon material extending between proximal balloon strap and the distal balloon strap. The maximum inflation capacity of the helios balloon is 0. 75 cc. Additional information obtained from the customer revealed that "extra air" was inserted into the balloon during testing outside the body of the patient. It is believed that the device failed when it was exposed to stresses beyond its maximum capabilities during use. Per conversation with the customer, an inservice is scheduled for this friday on use of the device. A review of the device history record identified rejects in final packaging for eight units with incorrect date of manufacture on the barcode and eight units for no english title on the label. A review of complaints against this lot number identified one additional complaint for balloon would not inflate which is associated with this event. Per qa inspection procedure, prior to shipment to a customer, 100% of devices are subjected to visual inspections of balloon material in the inflated and deflated state, visual inspection of balloon straps, inspection of bonding of the inflation lumen, inflation/deflation capability of the balloon, the ability of balloon to maintain inflated state for a minute and leak test of the inflated balloon. The instructions for use (ifu) provides instructions on testing of the balloon integrity before use. The user is instructed not to inflate the balloon beyond the stated maximum inflation capacity. Exceeding the maximum inflation capacity will not appreciably increase the diameter of the balloon and can cause balloon rupture. In addition, the ifu provides these 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. The first helios temporary pacing lead associated with this event is reported under mdr 1035166-2016-00080.

 
Event Description

The customer reported that during a diagnostic procedure, the patient went into complete heart block (chb) and required a temporary pacer. During testing of the helios temporary pacing lead balloon, the first balloon would not inflate. A second helios device was obtained for use. During testing of the second device, there was difficulty getting the balloon to function so additional air was inserted which resulted in bursting of the balloon. A third device was obtained and functioned without further problems. There was no report of any adverse patient effects from this event.

 
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Brand NameHELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON
Type of DeviceTEMPORARY PACING LEAD
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer Contact
jan flegeau
3816 desoto blvd.
palm harbor , FL 34683-1816
7279372511
MDR Report Key5610000
Report Number1035166-2016-00076
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/01/2018
Device MODEL NumberH05RH110U
Device Catalogue NumberH05RH110U
Device LOT NumberC1-10930
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/13/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2015
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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