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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/170/150 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/170/150 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 366137
Device Problem Material Puncture/Hole
Event Date 02/15/2019
Event Type  Malfunction  
Event Description

The passeo-18 balloon catheter was selected for the treatment of a calcified lesion. After lesion crossing and positioning the passeo-18 balloon could not be inflated and a pinhole was suspected.

 
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Brand NamePASSEO-18 2/170/150
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
Manufacturer Contact
6024 jean road
lake oswego , OR 97035
8772459800
MDR Report Key9158910
Report Number1028232-2019-04352
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device MODEL Number366137
Device Catalogue NumberSEE MODEL NO.
Device LOT Number07172045
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/31/2017
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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