MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430489
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 self-expandable stent system was selected for treatment.After successful stent implantation, the delivery system of the pulsar-18 t3 got stuck on the guidewire.A complete retraction was only possible with great force.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation confirmed that the inner shaft has fractured and separated from the stent system.The separated inner shaft fragment has a length of about 316 mm.The inner shaft is plastically deformed and the inner shaft diameter does not comply anymore with the specification, both indicating that the fracture and thus separation of the inner shaft were caused by application of a high tensile force.The stent has been successfully released and was thus not returned.The retractable shaft has been pulled too far into the stabilizer shaft which caused a severe wrinkling of the stabilizer shaft at the transition to the handle lever.The introducer sheath and the guidewire used in the intervention were not returned.Review of the product release documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The root cause for the complaint event is most likely related to the handling during device withdrawal.Please note that, according to the ifu, the user is advised to exercise care during handling to reduce the possibility of accidental breakage of the delivery system shaft.Also, the user is advised to ensure the guide wire is grasped once the system tip has been completely retracted from introducer.

• Brand Name: PULSAR-18 T3 5/40/135
• 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: 18057827
• Report Number: 1028232-2023-05623
• Device Sequence Number: 7018117
• Product Code: NIP
• UDI-Device Identifier: 07640130446878
• UDI-Public: (01)07640130446878(17)2607
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 07/01/2026
• Device Model Number: 430489
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06232123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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