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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 12/40/90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 12/40/90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 428794
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
A passeo-35 xeo balloon catheter was selected for treatment of an aneurysm in the ostial subclavian artery. The device was advance over the wire and inflated at subclavian artery to post dilate a covered stent. 10 bar pressure was applied. The balloon could not inflate further and leaking of contrast was observed in the fluoroscopy. Blood also observed in the syringe of the inflation device.
 
Event Description
A passeo-35 xeo balloon catheter was selected for treatment of an aneurysm in the ostial subclavian artery. The device was advance over the wire and inflated at subclavian artery to post dilate a covered stent. 10 bar pressure was applied. The balloon could not inflate further and leaking of contrast was observed in the fluoroscopy. Blood also observed in the syringe of the inflation device.
 
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Brand NamePASSEO-35 XEO 12/40/90
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 Key13471100
MDR Text Key285330123
Report Number1028232-2022-00628
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K142379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number428794
Device Catalogue NumberSEE MODEL NO.
Device Lot Number10192119
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2020
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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