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

Model Number	170-03-35015
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device received by celonova on 31-jul-2019; analysis is not yet complete.Complaints specialist performed visual analysis on the returned delivery system.Complaints specialist received the delivery system in the following condition: the center section of the stent is damaged/stretched and is off the balloon.The balloon is tightly folded, indicating that no inflation or deployment attempts were made.The stylet and sheath also returned with the device.Dimensional analysis on the returned device met product specifications.Functional analysis was not performed due to the condition of the returned device.Complaints specialist was unable to replicate stent dislodgement in a testing environment due to the condition of the returned device and due to procedural, anatomical circumstances, and / or other uncontrolled factors possibly related to the procedure itself.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.The investigation determined that a definitive conclusive cause is not able to be assigned to the reported complaint.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling; there is no evidence of a device deficiency.
Event or Problem Description
On (b)(6) 2019, when unpackaging a 3.5x15mm 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 3.5mm (length unknown) 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: 8890084
• Report Number: 3009306400-2019-00040
• Device Sequence Number: 2457126
• Product Code: MAF
• UDI-Device Identifier: 00879397000852
• UDI-Public: (01)00879397000852(17)220531(10)1905244001
• 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): 08/12/2019

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: 05/31/2022
• Device Model Number: 170-03-35015
• Device Catalogue Number: 170-03-35015
• Device Lot Number: 1905244001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1