MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/40/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430450
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a calcified lesion with 70 percent stenosis degree.After successful stent deployment resistance was felt while it was attempted to remove the system.Eventually the device fractured during withdrawal.All device parts were removed from the 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 and separated from the system.The inner shaft fragment has a length of about 216 mm and is severely deformed (i.E.Has elongated and calibrated down), indicating application of excessive force.The device tip which is connected to the inner shaft fragment is undamaged, all transitions are smooth.Inspection of the remainder of the device revealed no other damage or irregularity.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 root cause for the complaint event is most likely related to the handling during the procedure, i.E.Forcefully pulling the inner shaft out of the device.It should be noted that the ifu advises the user to exercise care during handling to reduce the possibility of deploying the stent prematurely, accidental breakage, bending or kinking of the delivery system shaft.

• Brand Name: PULSAR-18 T3 6/40/90
• 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: 10155366
• Report Number: 1028232-2020-02443
• Device Sequence Number: 13903318
• Product Code: NIP
• UDI-Device Identifier: 07640130446489
• UDI-Public: 07640130446489
• 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): 06/15/2020

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: 12/31/2020
• Device Model Number: 430450
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01201732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1