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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 6/40/80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 6/40/80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 357289
Device Problem Material Rupture (1546)
Patient Problem Injury (2348)
Event Date 06/22/2020
Event Type  Injury  
Event Description

The passeo-35 balloon was selected for treatment of an arteriovenous fistula dysfunction. After positioning the balloon was inflated up to 16 atm. During attempt to inflate a 2nd time with same pressure, the balloon ruptured and could not be withdrawn and was retrieved with an incision.

 
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Brand NamePASSEO-35 6/40/80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key10484028
MDR Text Key205337827
Report Number1028232-2020-03731
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK082933
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 09/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number357289
Device Catalogue NumberSEE MODEL NO.
Device LOT Number09191054
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/02/2019
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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