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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELECTRA EXTENDED HOOK-45 LEAD DELIVERY SYSTEM

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BIOTRONIK SE & CO. KG SELECTRA EXTENDED HOOK-45 LEAD DELIVERY SYSTEM Back to Search Results
Model Number 375527
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/14/2021
Event Type  Injury  
Event Description

The physician reported excessive blood loss during the use of this product, at approximately 100ml of blood. The procedure was completed without any further complication. Should additional information become available this file will be updated.

 
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Brand NameSELECTRA EXTENDED HOOK-45
Type of DeviceLEAD DELIVERY SYSTEM
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key12193473
MDR Text Key262416207
Report Number1028232-2021-04069
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110461
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number375527
Device Catalogue NumberSEE MODEL NO.
Device LOT Number7002297684
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 07/19/2021 Patient Sequence Number: 1
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