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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/12 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/12 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER Back to Search Results
Model Number 367004
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Event Description
A pantera leo coronary balloon catheter was selected for treatment of a severely calcified lesion (93 percent stenosis degree) in the severely tortuous mid lad. Pressure was applied (20 atm) but the balloon did not inflate properly. Contrast medium leaked from balloon.
 
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Brand NamePANTERA LEO 2.5/12
Type of DeviceBASIC CORONARY ANGIOPLASTY BALLOON 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 Key11544570
MDR Text Key241520706
Report Number1028232-2021-01362
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K163660
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 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number367004
Device Catalogue NumberSEE MODEL NO.
Device Lot Number08203082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2020
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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