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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 Date 07/16/2021
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 Key12252907
MDR Text Key264301460
Report Number1028232-2021-04309
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 Received07/29/2021
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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