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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 2.5/20 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

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BIOTRONIK AG PANTERA LEO 2.5/20 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER Back to Search Results
Model Number 367026
Device Problem Burst Container or Vessel (1074)
Patient Problems No Consequences Or Impact To Patient (2199); Discharge (2225)
Event Date 10/04/2017
Event Type  malfunction  
Manufacturer Narrative
It was intended to treat a severe calcified lesion (stenosis degree 95%) in the proximal lad. The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event. The technical investigation revealed that the balloon has obviously been inflated. However, microscopic inspection revealed a pinhole in the proximal part of the balloons and scratches in the balloon surface were observed nearby. The review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection. In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test. Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was determined. The final root cause for the reported event is most likely related to the severe calcification of the vessel.
 
Event Description
The panera leo balloon was inflated up to 20 atm to treat a severely calcified lesion with a stenosis degree of 95% in the lad, when suddenly a loss of pressure was noticed. The patient is an (b)(6) male.
 
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Brand NamePANTERA LEO 2.5/20
Type of DeviceBASIC CORONARY ANGIOPLASTY BALLOON CATHETER
Manufacturer (Section D)
BIOTRONIK AG
ackerstrasse 6
buelach CH-81 80
SZ CH-8180
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key7017932
MDR Text Key106927009
Report Number1028232-2017-04128
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K163660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model Number367026
Device Catalogue NumberSEE MODEL NO.
Device Lot Number05172121
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
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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