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

Model Number	170-03-35030
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The delivery system (without stent) was received by celonova 19-feb-2020.Complaints specialist performed applicable visual and dimensional analysis on the used returned delivery system.Complaints specialist received the delivery system in the following condition: balloon loosely folded, indicating that inflation or deployment attempts made; stent missing and guidewire notch damage noted.Applicable dimensional analysis on the returned device met product specifications.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) was performed.There were no non-conformances.The lot conforms to its predetermined specifications and requirements, including for crossing profile and stent retention.Stent 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.The most probable cause(s) of resistance against support catheter, and subsequent stent dislodgement, is most likely due to interaction with the support catheter during advancement, and / or inadvertent pressurization of delivery system during advancement since the delivery system was received with evidence of inflation attempt.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
During planned percutaneous coronary intervention (pci) for treatment of a lesion in an unspecified coronary vessel on (b)(6) 2020, a 3.5x30mm cobra pzf nanocoated stent system became stuck inside of a guideliner (size unspecified) during advancement and the stent dislodged in the guideliner.The guideliner with dislodged stent were withdrawn as a single unit and were discarded by site.Another same size cobra pzf¿ stent was advanced in same size guideliner without difficulty; the stent was deployed in the target lesion without issue.There were no adverse patient effects.Though requested, no additional information was provided due to hospital privacy policy.

• 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: 9775562
• Report Number: 3009306400-2020-00015
• Device Sequence Number: 2185025
• Product Code: MAF
• UDI-Device Identifier: 00879397000883
• UDI-Public: (01)00879397000883(17)220731(10)1907234004
• 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): 03/02/2020

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: 09/30/2022
• Device Model Number: 170-03-35030
• Device Catalogue Number: 170-03-35030
• Device Lot Number: 1907234004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1