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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/150/150 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/150/150 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 366129
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 06/16/2021
Event Type  malfunction  
Event Description
The physician intended to treat a severely calcified lesion (90 percent stenosis degree, vessel reference diameter 6 mm, lesion length 180 mm) in a mildly tortuous bifurcation of the left anterior tibial artery. A passeo-18 balloon catheter was used for the procedure. Initially, it was reported that the balloon of the complaint instrument burst and ruptured in the vessel. After additional correspondence with the local staff it was clarified that the complaint instrument was successfully inflated three times. After balloon deflation, the instrument was withdrawn during which the balloon tore off the catheter. Since the balloon could not be recovered, the patient underwent surgery. The balloon was successfully removed.
 
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Brand NamePASSEO-18 2/150/150
Type of DevicePERIPHERAL DILATATION 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 Key12370304
MDR Text Key268229971
Report Number1028232-2021-04800
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K072765
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
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number366129
Device Catalogue NumberSEE MODEL NO.
Device Lot Number11202139
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/26/2021 Patient Sequence Number: 1
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