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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/130 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/130 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 376301
Device Problem Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A passeo-18 balloon catheter was chosen for treatment. It was attempted to inflate the balloon up to 5 bar, but to keep it at 5 bar it was necessary to give more pressure. Eventually the passeo-18 had to be replaced by another balloon as it could not be used anymore. Lot number and event date are unavailable.
 
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Brand NamePASSEO-18 5/200/130
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 Key12252899
MDR Text Key264307893
Report Number1028232-2021-04308
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number376301
Device Catalogue NumberSEE MODEL NO.
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 Received09/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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