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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/90 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/90 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 376281
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Event Description
A passeo-18 balloon catheter was chosen for treatment. The balloon was placed properly inside the lesion. As the balloon was inflated up to 6 bar the pressure of the balloon would slowly turn down. To keep the balloon inflated at 6 bar it was necessary to keep on giving more pressure.
 
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Brand NamePASSEO-18 5/200/90
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 Key12540808
MDR Text Key273591468
Report Number1028232-2021-05349
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151744
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 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number376281
Device Catalogue NumberSEE MODEL NO.
Device Lot Number04215345
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2021
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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