MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/200/90; STENT

Model Number	430466
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment.The stent could not be released.Despite heavily turning the wheel, no release was possible.
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 the as-returned state the distal end of the braided shaft was located directly at the tip of the instrument and appeared not to be withdrawn at first sight.However, the stent is not crimped below braided shaft anymore and is missing.Inside the handle, the pullwire has separated from the retractable shaft.However, the retractable shaft could be moved without any resistance.At the contact point between the retractable shaft and the luer an indentation is visible, indicating that the shaft has been pulled back to the luer with force.On the fracture sites of the pullwire, a ductile tensile fracture surface is present, confirming that the wire has fractured due to a high tensile overload.Even after additional correspondence and personal visit with the local staff/physician, no further information could be obtained regarding the missing stent and the sequence of events.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 a 100 percent visual control of the stent area 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 6/200/90
• Common Device Name: STENT
• 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: 16103762
• Report Number: 1028232-2023-00054
• Device Sequence Number: 7552509
• Product Code: NIP
• UDI-Device Identifier: 07640130446649
• UDI-Public: (01)07640130446649(17)2506
• 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): 01/04/2023

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: 06/14/2025
• Device Model Number: 430466
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05225535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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