MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/30/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430508
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a calcified lesion.During withdrawal of the deliver system the distal part of the retractable shaft has fractured.The fractured part could be removed from patients body.
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 fractured inside the stopper shaft and separated from the system.In the as-returned state the inner shaft fragment was stuck inside a 4f cordis guiding catheter together with a 0.035 inch guidewire.About 38 mm of the inner shaft fragment protrude from the distal end of the guiding catheter.After dissecting the guiding catheter, it became apparent that the inner shaft was trapped inside the guiding catheter at the distal end of the 0.035 inch guidewire.The inner shaft has elongated and calibrated down, indicating application of a high tensile force.Review of the production documentation for the product detailed above confirmed that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The most probable root cause for the complaint event is related to the handling during the procedure, i.E.Forceful withdrawal of the instrument.Please note that, according to the ifu, the user is also advised to exercise care during handling to reduce the possibility of accidental breakage of the delivery system shaft.

• Brand Name: PULSAR-18 T3 7/30/135
• 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: 10769539
• Report Number: 1028232-2020-04726
• Device Sequence Number: 4087078
• Product Code: NIP
• UDI-Device Identifier: 07640130447066
• UDI-Public: 07640130447066
• 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): 10/30/2020

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: 07/08/2023
• Device Model Number: 430508
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06204174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1