MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430499
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 self-expandable stent system was selected for treatment.An attempt was made to push the pulsar-18 t3 over the v18 guidewire, but it remained stuck.Despite the noted friction, the device was pushed further.During this attempt, the stent was partially released.The device was removed.A second guidewire was inserted into the guidewire lumen of another pulsar-18 t3 from the other direction.Afterwards, this pulsar-18 t3 was used as usual, and the stent was implanted.
Additional Manufacturer Narrative
The stent was partially released outside of the patients body.Device was never inserted into the patient.The returned product was subjected to a detailed 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 the stent is not present anymore underneath the retractable shaft.The distal end of the retractable shaft is located about 6 mm proximal to the device tip although the safety button at the handle is in the locked position.Microscopic inspection revealed foreign material at the proximal end of the guidewire lumen which is potentially uv glue used for the fixation of the shafts inside the luer.Besides, a strong kink was observed in the device shaft at the distal end of the handle lever.The two 0.018 inch guidewires used in the intervention were returned separately.After straightening the kink at the distal end of the handle lever, both returned guidewires could be fully introduced.Increased friction was only felt when passing the kink at the handle lever.However, it seems likely that the kink was induced during the return shipment, and that the foreign material in the guidewire lumen has caused the increased friction of the guidewire during the intervention.The most probable root cause for the complaint event is therefore related to the manufacturing process.To prevent recurrence the respective internal departments were informed about this case.
Additional Manufacturer Narrative
The stent was partially released outside of the patients body.Device was never inserted into the patient.The most probable root cause was identified as adhesive residue/particles within the gw lumen.The adhesive residue/particles were identified as glue which is used for the fixation of the shafts in side of the luer.Therefore, the root cause for the complaint event is most likely related to the manufacturing process cutting of innershaft and/or gluing inner shaft / stopper shaft to luer connector.The identified problem triggered a corrective action.The root cause analysis identified a specification issue.Thus, the specification documents and work instructions have been optimized and the in-process control has been optimized.The risk assessment of the corrective action confirmed that the identified problem represents no risk to the health or safety of users, patients or third parties is present and the effectiveness test of the corrective action was successful.

• Brand Name: PULSAR-18 T3 6/40/135
• 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: 17214033
• Report Number: 1028232-2023-03208
• Device Sequence Number: 12315561
• Product Code: NIP
• UDI-Device Identifier: 07640130446977
• UDI-Public: (01)07640130446977(17)2603
• 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,Followup
• Report Date (Section B): 10/25/2023

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: 03/07/2026
• Device Model Number: 430499
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02234645
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 10/24/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/24/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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