MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 US 6/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	390729
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 peripheral stent system was selected for treatment of a pre-dilated severely calcified lesion in the mid sfa.During the deployment the trigger quit working.The handle was opened, and an attempt was made to deploy with secondary release, but the stent broke off and a part of the stent was removed.Patient was fine and recovering.
Additional Manufacturer Narrative
The procedure date was incorrect on the original report.The correct date is (b)(6) 2022.The returned instrument 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be the cause for the reported event.The technical investigation of the instrument revealed that the outer shaft has been retracted by about 300 mm.The stent has been fully released.Neither the stent nor stent fragments were returned for analysis.Therefore, a stent fracture can neither be confirmed nor denied.The returned instrument shows no signs of a release issue.The handle was returned completely assembled and fully functional.Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.The conducted technical investigations and review of the production documentation did not reveal a material defect or manufacturing deviation.

• Brand Name: PULSAR-18 US 6/150/135
• Common Device Name: 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 Key: 14380196
• Report Number: 1028232-2022-02471
• Device Sequence Number: 4874819
• Product Code: NIP
• UDI-Device Identifier: 07640130436664
• UDI-Public: 07640130436664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 390729
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08213766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown