MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 7/120/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	390738
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During deployment the pulsar-18 stent could only be partially released.
Additional Manufacturer Narrative
A technical analysis of the returned instrument and a review of the manufacturing history were conducted to evaluate whether there was any deviation that could account for the reported event.The technical investigation of the returned device revealed that the stentis partially released, 2/3 of the stent are not released and still crimpedunder the transparent outer shaft.Several kinks were observed at different locations of the device shaft.Further the outer shaft of the returned stent delivery system, which has to be retracted in order to release the stent, was found to be fractured inside the handle.The deformations indicate that the retractable outer shaft was impeded from movement due to unknown friction leading to an increased retraction force exceeding the fracture strength of the retractable outer shaft.Review of the production documentation verified that the instrument detailed above was manufactured according to specifications.The device fulfilled all the requirements of in-process and final inspection.The conducted technical investigations and review of the production documentation did not reveal a material defect or manufacturing deviation.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 7/120/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• MDR Report Key: 7889901
• Report Number: 1028232-2018-03202
• Device Sequence Number: 2726631
• Product Code: NIP
• UDI-Device Identifier: 07640130436756
• UDI-Public: (01)07640130436756
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 10/31/2020
• Device Model Number: 390738
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10175937
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1