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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 7/60/135; STENT, SUPERFICIAL FEMORAL ARTERY
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BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 7/60/135; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 377494
Device Problem Failure to Eject (4010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2020
Event Type  malfunction  
Event Description
A pulsar-18 peripheral stent system was selected for treatment of a lesion (80 percent stenosis degree) in a mildly tortuous proximal superior mesenteric artery.It was not possible to release the stent.Nothing happens by pulling the trigger.Another pulsar-18 was used to complete the intervention.
 
Manufacturer Narrative
The returned instrument was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned device revealed that the outer shaft has not been retracted.The stent is fully crimped under the retractable outer shaft.The locking tab has been removed from handle and its counterpart is missing.Also, one gear wheel is missing and one part of the assembly is in an incorrect position inside the handle.Upon re-assembly of the relevant parts the stent could be successfully released.During production a picture is taken showing a correctly assembled handle with all parts being present.It can therefore be excluded beyond reasonable doubt that the defect was already present on delivery of the instrument.Review of the production documentation for the product detailed above confirmed that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no material or manufacturing related root cause could be identified.
 
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Brand Name
PULSAR-18 7/60/135
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key10853792
MDR Text Key216672211
Report Number1028232-2020-05006
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
PMA/PMN Number
P160025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number377494
Device Catalogue NumberSEE MODEL NO.
Device Lot Number12191097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received01/12/2021
Supplement Dates FDA Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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