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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/15 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/15 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER Back to Search Results
Model Number 367015
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2020
Event Type  malfunction  
Event Description
A pantera leo coronary balloon catheter was selected for treatment. When removing the balloon protector, the transportation wire/stylet was found kinked and punctured the physicians glove, which cause bleeding on physicians finger.
 
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Brand NamePANTERA LEO 2.5/15
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 Key10737627
MDR Text Key213177640
Report Number1028232-2020-04640
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 10/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number367015
Device Catalogue NumberSEE MODEL NO.
Device Lot Number05201926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2020
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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