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

Model Number	170-03-25018
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received (b)(6) 2019.It was noted during review of returned device analysis on 20-jun-2019 that, while the stent was received crimped to the balloon, the stent later came off the balloon while manipulating the device to take photos of the balloon at the returned device lab.A review of the lot history record (lhr) was performed.There were no non-conformances.The devices from this lot conforms to their predetermined specifications and requirements, including for crossing profile.Advancement difficulty and dislodgement are captured in the risk assessment as known potential hazards.Investigation is not yet complete.A follow-up report will be submitted with relevant additional information.
Event or Problem Description
On (b)(6) 2019, patient presented for percutaneous coronary intervention (pci) of a lesion in the right coronary artery (rca).A 2.5x18mm cobra pzf coronary stent system was advanced but was unable to cross.Another smaller unspecified stent crossed and was deployed in the lesion.There were no reported adverse patient effects.While the stent was received crimped to the balloon, after disinfecting the device, the stent came off the balloon while manipulating the device during analysis.Additional information was requested.

• 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: 8789024
• Report Number: 3009306400-2019-00032
• Device Sequence Number: 1937713
• Product Code: MAF
• UDI-Device Identifier: 00879397000685
• UDI-Public: (01)00879397000685(17)210430(10)1804054001
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: 04/30/2021
• Device Model Number: 170-03-25018
• Device Catalogue Number: 170-03-25018
• Device Lot Number: 1804054001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1