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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a mildly calcified lesion (30-40 percent stenosis degree) in a mildly tortuous sfa.After placing and deployment of the stent in the target lesion, the device was easily removed.After withdrawal it was detected that the inner shaft was separated from the rest of the system on the guide wire.
Additional Manufacturer Narrative
The returned instrument was subjected to a 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 of the returned device revealed that the inner shaft has separated from the system.The inner shaft has fractured inside the luer at the transition between stopper shaft and inner shaft.The inner and outer diameters of the inner shaft still comply with the specification.Simulations have shown that a mechanical damage of the inner shaft, most likely caused during manufacturing, can lead to a damage pattern as observed in the complaint instrument.To prevent recurrence the respective internal departments were informed about this case and we are reviewing our quality systems processes.

• 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
• MDR Report Key: 9735231
• Report Number: 1028232-2020-00853
• Device Sequence Number: 10851565
• Product Code: NIP
• UDI-Device Identifier: 07640130446946
• UDI-Public: 07640130446946
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 09/30/2020
• Device Model Number: 430496
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09197098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1