MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PULSAR-18 T3 6/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430504
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a 100 percent stenosis in the sfa.After positioning and releasing one third of the pulsar-18 t3 stent it was very difficult to release the rest of the stent.
Additional 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process could be the cause for the reported event.The technical investigation revealed that the outer shaft has been retracted by about 160 mm and the stent has been fully released.The winding wheel at the handle could not be further rotated.After opening the handle it became apparent that the pull wire has not been correctly routed.This caused an entanglement of the pull wire with the winding wheel as well as a blockage of the hose at the proximal end of the pull wire.A simulation with a reference pulsar-18 t3 showed that the same damage pattern could be reproduced by wrongly routing the pull wire inside the handle.These findings indicate that the root cause for the complaint event is most likely related to the manufacturing process, i.E.Assembly of the handle.To prevent recurrence the respective internal departments were informed about this case and we are reviewing our quality systems processes.

• Brand Name: PULSAR-18 T3 6/150/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10978993
• Report Number: 1028232-2020-05412
• Device Sequence Number: 4168962
• Product Code: NIP
• UDI-Device Identifier: 07640130447028
• UDI-Public: 07640130447028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: 430504
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10202684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1