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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2/40/150 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2/40/150 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 380320
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2022
Event Type  malfunction  
Event Description
The passeo-14 balloon catheter was selected for treatment of a mildly calcified lesion with 80 percent stenosis degree in the posterior tibial artery. The passeo-14 was advanced over the wire and inflated at 12 bar. The balloon couldn't inflate further and leaking of contrast was observed in the fluoroscopy.
 
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Brand NamePASSEO-14 2/40/150
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 Key15129243
MDR Text Key296866486
Report Number1028232-2022-03848
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K152240
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,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380320
Device Catalogue NumberSEE MODEL NO.
Device Lot Number02221461
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2022
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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