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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 3.5/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
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BIOTRONIK AG PANTERA LEO 3.5/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER Back to Search Results
Model Number 367008
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2018
Event Type  malfunction  
Event Description
Ous mdr - during the procedure a tip deformation was noticed.
 
Manufacturer Narrative
The technical investigation of the affected device revealed a fracture of the hypotube, distal to the kink protector.The reported tip damage could not be confirmed.The cross section of the hypotube was not circular, which indicates that the hypotube most likely fractured as a result of significant bending.The balloon is well folded and shows no signs of inflation.Review of the manufacturing history of the production lot did not reveal any nonconformity.The complaint instrument was manufactured according to specifications and successfully passed all in-process inspections, as well as the final inspection.Based on the conducted investigation of the device under complaint, no manufacturing related root cause could be determined.
 
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Brand Name
PANTERA LEO 3.5/12
Type of Device
BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
Manufacturer (Section D)
BIOTRONIK AG
ackerstrasse 6
buelach CH-81 80
SZ  CH-8180
MDR Report Key8203284
MDR Text Key131707165
Report Number1028232-2018-04521
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K163660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model Number367008
Device Catalogue NumberSEE MODEL NO.
Device Lot Number08183809
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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