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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 5/100/130; CATHETER
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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 5/100/130; CATHETER Back to Search Results
Model Number 428889
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2023
Event Type  malfunction  
Event Description
A passeo-35 xeo balloon catheter was selected for pre-dilatation of a moderately calcified lesion in the mildly tortuous proximal to mid sfa.It was not possible to inflate the balloon, even the pressure was held at 9 atm.The inflation device was checked and no problem was found.A second attempt of inflation was made but the balloon still did not inflate.
 
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Brand Name
PASSEO-35 XEO 5/100/130
Type of Device
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 Key18242797
MDR Text Key329929918
Report Number1028232-2023-06061
Device Sequence Number1
Product Code LIT
UDI-Device Identifier07640130452602
UDI-Public(01)07640130452602(17)2603
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K222065
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number428889
Device Catalogue NumberSEE MODEL NO.
Device Lot Number02235665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2023
Date Device Manufactured03/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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