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

Model Number	430499
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment.The stent system was difficult to flush.The system barely passed over the wire.The stent could not be deployed.
Additional Manufacturer Narrative
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 guidewire used in the intervention was not returned.Flushing of the instrument and insertion of a 0.018 inch reference guidewire was impossible as it was blocked by a particle.The particle was detected inside the guidewire lumen of the instrument.The particle was identified as glue which is used for the fixation of the shafts inside of the luer.The root cause for the complaint event is therefore most likely related to the manufacturing process.To prevent recurrence the respective internal departments were informed about this case.
Additional Manufacturer Narrative
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 glueing inner shaft / stopper shaft to luer connector.The identified problem triggered a corrective action.The root cause analysis identified an 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: 15726906
• Report Number: 1028232-2022-05670
• Device Sequence Number: 7542466
• Product Code: NIP
• UDI-Device Identifier: 07640130446977
• UDI-Public: (01)07640130446977(17)2505
• 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): 10/24/2023

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: 05/18/2025
• Device Model Number: 430499
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04220962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 10/20/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/13/2022; 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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