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

Model Number	170-03-35030
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received 23-jul-2020.Complaints specialist performed applicable visual and dimensional analysis on the returned device.Blood was noted on the stent (possibly due to handling with bloody gloves or insertion through hemostatic valve, if attempted); stent was dislodged, with extensive stent damage noted.Complaints specialist was unable to replicate stent damage and dislodgement in a testing environment due to the condition of the returned 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 hemostatic valve, if insertion was attempted.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) 2020, while unpackaging a 3.5x30 cobra pzf¿ nanocoated coronary stent system for a planned percutaneous coronary intervention (pci), stent damage was noted.Another 3.5x30 cobra pzf¿ nanocoated coronary stent system was unpackaged; stent damage was also observed on this device and the stent dislodged from the balloon prior to entering the patient.There were no reported adverse patient effects.Though requested, no additional information was provided by the site.

• 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
• MDR Report Key: 10393552
• Report Number: 3009306400-2020-00022
• Device Sequence Number: 3446619
• Product Code: MAF
• UDI-Device Identifier: 00879397000883
• UDI-Public: (01)00879397000883(17)221130(10)1911114001
• Combination Product (Y/N): N
• 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): 08/11/2020

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: 11/30/2022
• Device Model Number: 170-03-35030
• Device Catalogue Number: 170-03-35030
• Device Lot Number: 1911114001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1