PULSAR-18 5/150/135 366835 SEE MODEL NO.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for PULSAR-18 5/150/135 366835 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.

Event Text Entries

[186117687] The pulsar-18 stent system was chosen for the treatment of a calcified lesion in the sfa. After positioning at the target lesion it was not possible to release the stent.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1028232-2020-01307
• MDR Report Key: 9838823
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-03-17
• Date of Report: 2020-03-13
• Date of Event: 2020-02-13
• Date Mfgr Received: 2020-03-13
• Device Manufacturer Date: 2019-09-04
• Date Added to Maude: 2020-03-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 6024 JEAN ROAD
• Manufacturer City: LAKE OSWEGO OR 97035
• Manufacturer Country: US
• Manufacturer Postal: 97035
• Manufacturer Phone: 8772459800
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PULSAR-18 5/150/135
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Product Code: NIP
• Date Received: 2020-03-17
• Model Number: 366835
• Catalog Number: SEE MODEL NO.
• Lot Number: 08193321
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOTRONIK AG, BUELACH, SWITZERLAND
• Manufacturer Address: ACKERSTRASSE 6 BUELACH CH-8180 CH CH-8180

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-17