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

Model Number	170-03-35030
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested (stent and delivery system), however, the site is unable to locate the complaint device.A review of the lot history record (lhr) was performed.There were no non-conformances.The lot conforms to its predetermined specifications and requirements, including for stent retention.Risk assessment review indicates that stent damage and dislodgement are captured as known potential occurrences.Though unable to be confirmed, potential causes of stent damage and dislodgement (before use) may include inadvertent rough handling during sheath removal and/or interaction between stent and its protective sheath.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.Device coding 2017: it was reported that the stent was not inspected prior to use.It should be noted that, per cobra pzf us commercial instructions for use (ifu) las 0147-01, revision c, step 12.2 prior to use states: remove protective cover and stylet by gently grasping the distal end of the cover and withdrawing distally.Verify that the stent is located between the radiopaque markers.Note: do not use if any defects are noted.
Event or Problem Description
On (b)(6) 2020, a planned percutaneous coronary intervention (pci) was performed using 3.5x30 cobra pzf nanocoated coronary stent system.The physician advanced the cobra stent system to the target lesion ; when inflating the stent system, the physician discovered that the stent was not on the balloon.The stent was found damaged/dislodged, stuck inside of its protective sheath packaging (occurred outside of patient prior to insertion).There were no reported adverse patient effects.Reportedly, the stent had not been inspected prior to introducing delivery system into patient.The target lesion was treated successfully with another cobra stent.Though requested, 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: 10522414
• Report Number: 3009306400-2020-00025
• Device Sequence Number: 3203951
• Product Code: MAF
• UDI-Device Identifier: 00879397000883
• UDI-Public: (01)00879397000883(17)221231(10)1912104004
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 12/31/2022
• Device Model Number: 170-03-35030
• Device Catalogue Number: 170-03-35030
• Device Lot Number: 1912104004
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1