• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 6/60/135; STENT, SUPERFICIAL FEMORAL ARTERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 6/60/135; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 377489
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Event Description
A pulsar-18 self-expandable stent system was advanced to the mildly calcified lesion (78 percent stenosis degree) in the moderately tortuous mid sfa, but the stent could not be released.Another stent was used to finish the procedure.
 
Manufacturer Narrative
28-may-2024 additional information: after additional correspondence with the local staff, it was clarified that the stent was released outside patient after device withdrawal by the physician.The physician further confirmed that he did not remember anything got stuck during the intervention.The returned product was subjected to a detailed 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 affected device was returned with the stent being fully released stent and located on the proximal portion of the device shaft.However, the local staff later clarified that the device was manipulated after the reported event since the stent was released outside patient after device withdrawal.The outer shaft has been retracted by about 46 mm.The outer shaft is constricted, kinked and has buckled at several locations.Outside of the deformed zones, the shaft dimensions comply with the specification.The proximal stent stopper shows mild compression marks and the proximal end of inner shaft is compressed.The findings indicate that the stent was blocked and pulled against the proximal stent stopper when the outer shaft was retracted.The blockage of the stent was most likely related to uncommonly high friction between the stent and the retractable outer shaft.Moreover, the device tip shows severe indentations, indicating that the device may got stuck.However, after additional correspondence with the local staff this could not be confirmed.Review of the production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was identified.The final root cause for the complaint event could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSAR-18 6/60/135
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key18890307
MDR Text Key337553236
Report Number1028232-2024-01382
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P170030
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 05/28/2024
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 Model Number377489
Device Catalogue NumberSEE MODEL NO.
Device Lot Number06235221
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received03/12/2024
Supplement Dates Manufacturer Received05/28/2024
Supplement Dates FDA Received05/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-