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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. 5F TEMPORARY BIPOLAR PACING LEAD WITH BALLOON ELECTRODE, PACEMAKER, TEMPORARY

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OSCOR INC. 5F TEMPORARY BIPOLAR PACING LEAD WITH BALLOON ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number H05110U
Device Problem Material Rupture
Event Date 09/13/2018
Event Type  Malfunction  
Manufacturer Narrative

Our investigation is still in progress, follow up report will be submitted if we found any further addtional informtion.

 
Event Description

It was reported that during implanting the electrode for temporary stimulation of the heart, the helios balloon was inflated to 3mm and burst. The syringe used was the one supplied in the kit together with the helios. The issue was resolved by opening another helios unit and inflating to 1mm. No additional information is available and no other adverse event was reported.

 
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Brand Name5F TEMPORARY BIPOLAR PACING LEAD WITH BALLOON
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
Manufacturer Contact
doug myers
3816 desoto blvd
palm harbor , FL 34683
7279372511
MDR Report Key7944802
Report Number1035166-2018-05174
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/01/2020
Device MODEL NumberH05110U
Device Catalogue NumberH05110U
Device LOT NumberC1-13586
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/21/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/19/2017
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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