MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/80/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430461
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a moderately calcified pre-dilated lesion in a mildly tortuous sfa.After the device was advanced, the stent could not be released and the device was therefore removed.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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 no material or manufacturing related root cause could be identified.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 T3 6/80/90
• 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: 9965731
• Report Number: 1028232-2020-01724
• Device Sequence Number: 2077208
• Product Code: NIP
• UDI-Device Identifier: 07640130446595
• UDI-Public: 07640130446595
• 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): 04/14/2020

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: 11/30/2020
• Device Model Number: 430461
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12190556
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1