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

Model Number 430462

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10478573
• MDR Text Key: 205166655
• Report Number: 1028232-2020-03709
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446601
• UDI-Public: 07640130446601
• Combination Product (y/n): N
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1