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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/120/150; PERIPHERAL DILATATION CATHETER
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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/120/150; PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 366126
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2023
Event Type  malfunction  
Event Description
A passeo-18 balloon catheter was selected for treatment of an arteriovenous fistula.After insertion, during inflation of the device, it was noticed that the balloon was leaking.Another balloon was used to finish the procedure.The patient was stable and discharged home.
 
Event Description
A passeo-18 balloon catheter was selected for treatment of an arteriovenous fistula.After insertion, during inflation of the device, it was noticed that the balloon was leaking.Another balloon was used to finish the procedure.The patient was stable and discharged home.
 
Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is inflated before balloon folding followed by a pressure test and a helium leakage test to confirm the air tightness.All released instruments of the relevant lot passed these tests.The instrument was delivered in a leak-proof and pressure-tight condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.
 
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Brand Name
PASSEO-18 2/120/150
Type of Device
PERIPHERAL 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 Key18004694
MDR Text Key326516228
Report Number1028232-2023-05421
Device Sequence Number1
Product Code LIT
UDI-Device Identifier07640130414686
UDI-Public(01)07640130414686(17)2506
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 Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number366126
Device Catalogue NumberSEE MODEL NO.
Device Lot Number05222623
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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