• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OSCOR INC. GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number D141101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non specific EKG/ECG Changes (1817); Ventricular Fibrillation (2130)
Event Date 03/15/2022
Event Type  Injury  
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
 
Event Description
It was reported during a heliostar ee procedure after the transseptal puncture, the abbott fixed sheath (sl1) was exchanged by the guidestar 13. 5f. Just after introducing the heliostar balloon, st elevation was noticed in the ecg, followed by approximately 6 episodes of ventricular fibrillation (10-15 beats each, more or less). Coronariography was performed, air embolism was suspected but no evidence found in the x-ray imaging. After 15 minutes the ecg was normal again, the procedure was continued and was successfully completed. No patient consequences were reported. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGUIDESTAR¿ STEERABLE GUIDING SHEATH
Type of DeviceINTRODUCER, CATHETER
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
daniel naut
3816 desoto blvd.
palm harbor, FL 34683
7279372511
MDR Report Key14074880
MDR Text Key289005206
Report Number1035166-2022-00043
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD141101
Device Catalogue NumberD141101
Device Lot NumberC8-19616
Was Device Available for Evaluation? No
Date Manufacturer Received08/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/11/2022 Patient Sequence Number: 1
-
-