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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 3.5/8 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

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BIOTRONIK AG PANTERA LEO 3.5/8 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER Back to Search Results
Model Number 366997
Device Problems Positioning Failure (1158); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
It was reported that the balloon of the complaint instrument did not inflate and the device fractured during withdrawal. All parts of the device could be removed from the patient. The technical investigation revealed that the device has fractured at the level of the hypotube. The cross section of the hypotube revealed that the hypotube fractured as a result of significant bending. A laboratory simulation confirmed that the hypotube needs to be bent more than 160 degrees in order to be weakened enough to break when pulled straight and requires cyclic bending (about 20) at smaller angles for fracture. The balloon could be inflated without findings. 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 being subject to this complaint, no manufacturing related root cause could be determined.
 
Event Description
Ous mdr - the balloon could not be inflated and fractured on the proximal guide during withdrawal.
 
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Brand NamePANTERA LEO 3.5/8
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 Key7087137
MDR Text Key161878707
Report Number1028232-2017-04441
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 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model Number366997
Device Catalogue NumberSEE MODEL NO.
Device Lot Number08172765
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 Received01/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2017
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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