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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/200/90 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/200/90 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 376280
Device Problem Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 06/29/2020
Event Type  malfunction  
Event Description
A passeo-18 balloon catheter was chosen for treatment. The balloon burst during inflation at 8 atm.
 
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Brand NamePASSEO-18 4/200/90
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 Key13010189
MDR Text Key282272670
Report Number1028232-2021-06764
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K072765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number376280
Device Catalogue NumberSEE MODEL NO.
Device Lot Number02201232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2020
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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