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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 ELECTRODE, PACEMAKER, TEMPORARY

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OSCOR INC. HELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number H05110U
Device Problem Material Rupture
Event Date 12/07/2018
Event Type  Malfunction  
Manufacturer Narrative

Conclusion not yet available as the investigation is on-going. A follow-up will be submitted as soon as the investigation is complete.

 
Event Description

The customer reported when inserting the "osocr" device 5f catheter into "diffrent" brand 6f catheter, the balloon cracked. No additional information is available and no other adverse event was reported.

 
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Brand NameHELIOS 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 habror FL 34683
Manufacturer Contact
doug myers
3816 desoto blvd
palm habror , FL 34683
7279372511
MDR Report Key8206739
Report Number1035166-2018-00140
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH05110U
Device Catalogue NumberH05110U
Device LOT NumberC1-14068
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/31/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/12/2018
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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