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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 4/80/135; STENT, SUPERFICIAL FEMORAL ARTERY
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BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 4/80/135; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 377480
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Event Description
A pulsar-18 stent system was selected for treatment of a severely calcified lesion (stenosis degree: 95 percent) in a severely tortuous left sfa.After pre dilatation, the pulsar-18 was inserted, but the stent was released during the delivery, even though the red safety tab was not removed.The stent was removed from the patient and another stent was used to finish the procedure.
 
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Brand Name
PULSAR-18 4/80/135
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
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 Key19154469
MDR Text Key340742371
Report Number1028232-2024-02202
Device Sequence Number1
Product Code NIP
UDI-Device Identifier07640130430464
UDI-Public(01)07640130430464(17)2403
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P160025
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
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model Number377480
Device Catalogue NumberSEE MODEL NO.
Device Lot Number03213432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2024
Date Device Manufactured04/23/2021
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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