MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/100/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430452
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a calcified lesion in a tortuous sfa.After successful deployment of the stent the device was removed from the patients body.Then it was detected that the inner shaft remained on the guide wire and was separated from the system.
Additional Manufacturer Narrative
The returned product 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 this event.The technical investigation of the returned instrument revealed that the inner shaft has fractured in three parts and has detached from the luer connector.The three inner shaft fragments are severely damaged, indicating application of excessive forces.The catheter is severely kinked at the transition from handle lever to stabilizer shaft.The position of one of the inner shaft fractures coincides with this kink.Simulations have shown that the inner shaft must have fractured after enduring higher forces which do not occur during normal retraction of the device.The same level of damage of the inner shaft could only be reconstructed by mishandling, i.E.Forcefully pulling the inner shaft out of the device.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.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 5/100/90
• 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: 9838857
• Report Number: 1028232-2020-01306
• Device Sequence Number: 2886103
• Product Code: NIP
• UDI-Device Identifier: 07640130446502
• UDI-Public: 07640130446502
• 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): 03/13/2020

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: 02/29/2020
• Device Model Number: 430452
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02194388
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1