MAUDE Adverse Event Report: CELONOVA BIOSCIENCES, INC. COBRA PZF; STENT CORONARY DELIVERY SYSTEM

Catalog Number	170-03-25015
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received by celonova biosciences on 13-dec-2018.Device analysis is not yet complete.A review of the lot history record (lhr) was performed.There were no non-conformance's.The lot conforms to its predetermined specifications and requirements, including for stent retention.Stent damage and dislodgement are captured in the risk assessment as known potential hazards.Investigation is not yet complete.A follow-up report with relevant additional information will be submitted.
Event or Problem Description
On (b)(6) 2018, while prepping a 2.5x15mm, cobra pzf nanocoated coronary stent system for use in a percutaneous coronary intervention procedure, the stent came off of the balloon and stent damage was noted (the stent struts appeared to be mangled).There was no patient involvement.Additional information was requested.

• Brand Name: COBRA PZF
• Common Device Name: STENT CORONARY DELIVERY SYSTEM
• Manufacturer (Section D): CELONOVA BIOSCIENCES, INC.; 5840 el camino real; suite 111; carlsbad CA 92008 8894
• MDR Report Key: 8197438
• Report Number: 3009306400-2018-00082
• Device Sequence Number: 1722166
• Product Code: MAF
• UDI-Device Identifier: 00879397000678
• UDI-Public: (01)00879397000678(17)210228(10)1802124001
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: 160014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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: 02/28/2021
• Device Catalogue Number: 170-03-25015
• Device Lot Number: 1802124001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1