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

Model Number	170-03-35024
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device received by celonova on (b)(6) 2019.A review of the lot history record (lhr) revealed no non-conformances related to the reported adverse event.The devices from this lot conforms to its predetermined specifications and requirements, including for stent retention.Dislodgement is captured in the risk assessment as a known potential hazard.Investigation is not yet complete.A follow-up report will be submitted with additional relevant information.
Event or Problem Description
On (b)(6) 2019, when unpackaging a 3.5x24mm cobra pzf¿ nanocoated coronary stent system, the stent sheath and stylet was removed with very little resistance when the stent came off with the sheath (the stent was reportedly stuck to its protective cover).The device was not flushed or prepped prior to sheath removal.The device was not used in the patient.A 3.5x30mm cobra pzf stent was used prepped and deployed in the patient without issue.No additional information was provided.

• 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: 8856288
• Report Number: 3009306400-2019-00039
• Device Sequence Number: 11362050
• Product Code: MAF
• UDI-Device Identifier: 00879397000876
• UDI-Public: (01)00879397000876(17)220331(10)1903014001
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P160014
• 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): 08/02/2019

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: 03/31/2022
• Device Model Number: 170-03-35024
• Device Catalogue Number: 170-03-35024
• Device Lot Number: 1903014001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1