MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/100/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430462
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 peripheral stent system was selected for treatment.During the procedure the inner unsterile pouch was handed to the scrub nurse and placed onto the sterile field.Then the inner unsterile pouch was opened up on the sterile field, the sterile tray was removed and the device was implanted.
Additional Manufacturer Narrative
Neither the complaint instrument nor the packaging was returned for technical investigation.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 verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.The ifu clearly states that the foil pouch within the outer packaging is not a sterile barrier.The inner pouch within the foil pouch is the sterile barrier.Only the contents of the inner pouch are sterile.The outer surface of the inner pouch is not sterile.Furthermore, the warning sign on the aluminum pouch clearly states: this foil pouch is not a sterile barrier.Only the contents of the inner pouch can be placed into the sterile field.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The root cause for the complaint event is related to the handling of the cathlab staff during the preparation for the intervention.

• Brand Name: PULSAR-18 T3 6/100/90
• 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: 10478573
• Report Number: 1028232-2020-03709
• Device Sequence Number: 2536393
• Product Code: NIP
• UDI-Device Identifier: 07640130446601
• UDI-Public: 07640130446601
• 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): 09/01/2020

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: 04/09/2023
• Device Model Number: 430462
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03203676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1