MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/200/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430496
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 self-expandable stent system was selected for treatment of the sfa.The pulsar-18 t3 was introduced over a v18 bsx wire but could not pass the hemostatic valve of the 4 french cordis sheath.Some force was needed when the stent deployed partially.The sds system could be withdrawn out of the sheath without any problem.
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manufacturing process could be the cause for this event.The technical investigation revealed that the outer shaft has been retracted by about 6 mm.The stent has been partially released inside the introducer sheath.The outer shaft is compressed and pinched at two locations in its distal portion, indicating application of a pushing force despite meeting resistance.In the stent area the outer layer of the outer shaft is scraped off.Outside of the deformed zone the outer shaft diameter complies with the specification.Inspection of the remainder of the device revealed no other damage or irregularity.The introducer sheath used in the intervention was returned separately.The returned introducer sheath shows no obvious damage or irregularity.The inner diameter of the introducer sheath was found to be 1.44 mm.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.The root cause for the complaint event is most likely related to a tolerance issue with the introducer sheath used in the intervention.

• Brand Name: PULSAR-18 T3 5/200/135
• 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: 15988040
• Report Number: 1028232-2022-06477
• Device Sequence Number: 6208785
• Product Code: NIP
• UDI-Device Identifier: 07640130446946
• UDI-Public: (01)07640130446946(17)2508
• 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): 12/14/2022

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: 08/29/2025
• Device Model Number: 430496
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07223470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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