MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430509
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment.Stent was flushed as per usual and was advanced over an 0.018 wire through a 4f fortress sheath.While advancing the device over the wire there was friction, and it was not moving forward.After removal of the device, it was detected that a quarter of the stent was already deployed.The stent was not exposed as it was being advanced into the hub of the sheath.The red lock button was not depressed, and the deployment wheel not used.Another 7mm stent was used through the same sheath without complications.
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.In addition, one photograph of the affected instrument was reviewed.The technical investigation revealed that the outer shaft has been retracted by about 7 mm.The stent has been partially released inside the introducer sheath.The outer shaft is compressed in its distal portion, indicating application of a pushing force despite meeting resistance.Outside of the deformed zone the outer shaft diameter complies with the specification.In the as-returned state the safety button at the handle was partially pressed down.Inspection of the remainder of the device revealed no other damage or irregularity.Due to the state of the instrument a simulation with a reference introducer sheath was not conducted.The introducer sheath used in the intervention was not returned.The photograph provided shows the affected instrument.The stent is partially released.The safety button at the handle is not pressed down which is line with the physicians event description but does not match with the state of the returned instrument.It therefore seems likely that the safety button was partially pressed down after the actual complaint event (e.G.During repacking for the return shipment).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.During final inspection, the outer shaft of every stent system undergoes visual inspection and a 100 percent control of the outer shaft diameter is performed.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 T3 7/40/135
• 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: 15372664
• Report Number: 1028232-2022-04563
• Device Sequence Number: 6324287
• Product Code: NIP
• UDI-Device Identifier: 07640130447073
• UDI-Public: (01)07640130447073(17)2411
• 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): 09/02/2022

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: 11/24/2024
• Device Model Number: 430509
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10215293
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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