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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/40/90 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/40/90 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 357461
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2022
Event Type  malfunction  
Event Description
A passeo-18 balloon catheter was chosen for treatment of a severely calcified lesion (100 percent stenosis degree) in the mildly tortuous distal popliteal artery. It was not possible to inflate the passeo-18 balloon catheter due to a balloon rupture.
 
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Brand NamePASSEO-18 4/40/90
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 Key14431579
MDR Text Key291969698
Report Number1028232-2022-02569
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number357461
Device Catalogue NumberSEE MODEL NO.
Device Lot Number11215643
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2021
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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