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

Model Number 366818

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

In the worst, but unlikely case, the tip could come off the device during the procedure, embolize distally and lead to artery obstruction.As a cautionary measure biotronik is withdrawing the concerned lots from the market.This voluntary field safety corrective action affects only the lots of the pulsar-18 stent systems listed and no other pulsar-18 stent system lots.

Event Description

Ous mdr - it was determined that due to a manufacturing issue, pulsar-18 stent systems from the lots listed did not meet the specifications for the tip tensile strength.No complaints or patient incidents related to this issue have been reported to biotronik so far.This is a list of size, model numbers and lot numbers affected: size: 7/40/135 model: 377493 lot: 12173610, size: 4/20/135 model: 377476 lot:12174145, size: 6/20/135 model: 377486 lot: 12174146, size: 6/150/90 model: 366820 lot: 12174363, size: 5/170/90 model: 366816 lot: 01180140, size: 6/100/90 model: 355818 lot: 01180366, size: 6/100/90 model: 366818 lot: 01180381, size: 6/100/90 model: 366818 lot: 01180465, size: 5/120/135 model: 366834 lot: 01181147, size: 7/100/135 model: 366843 lot: 01181148, size: 4/100/135 model: 366828 lot: 01182456, size: 6/20/135 model: 377486 lot: 01182837.No lots shipped to the us were affected.

• Brand Name: PULSAR-18
• Type of Device: STENT, SUPERFICIAL, FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 7378182
• MDR Text Key: 103813307
• Report Number: 1028232-2018-01064
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 366818
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01180465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1