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	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is (b)(6).The device was requested but has been discarded by the site.The lot history record (lhr) review 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.Though unable to be confirmed, potential causes of dislodgement ex-vivo may include inadvertent rough handling during sheath removal and/or inadvertent slight inflation of balloon prior to sheath removal.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
After unpackaging a 3.5x24mm cobra pzf¿ nanocoated stent system without issue on (b)(6) 2019, for planned use in a percutaneous coronary intervention procedure, the stent came off balloon when technician was pulling negative pressure during preparation with contrast.The device was not introduced into the patient at any time.Another same size cobra device was prepped and deployed 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: 9273010
• Report Number: 3009306400-2019-00064
• Device Sequence Number: 16617413
• Product Code: MAF
• UDI-Device Identifier: 00879397000876
• UDI-Public: (01)00879397000876(17)200930(10)1709134001
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/04/2019

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: 09/30/2020
• Device Model Number: 170-03-35024
• Device Catalogue Number: 170-03-35024
• Device Lot Number: 1709134001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1