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

Model Number	170-03-40024
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	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Though requests were made, the device was not received; it is presumed discarded.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 for stent retention.Risk assessment review indicates that advancement difficulty and stent dislodgement are captured as known potential hazards.The investigation determined that a definitive conclusive cause is not able to be assigned to the reported complaint.Though unable to be confirmed, in this case, inability to cross and subsequent stent dislodgement may possibly be attributed interaction with challenging vessel morphology, and / or a hemostatic valve.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, a (b)(6)-year old female patient evaluated with cardiac computerized tomography found 90% calcified lesion in the moderately tortuous proximal to mid left anterior descending (lad) coronary artery presented for planned percutaneous coronary intervention (pci).After pre-dilatation, an attempt was made to cross the lesion, via femoral access, with a 4.0x24mm cobra pzf¿ coronary stent system but the stent system was unable to cross.While retracting the undeployed stent system through the tuohy hemostatic valve, the stent dislodged inside of the valve, outside of patient body.There were no reported adverse patient effects.Though additional information was requested, it was not provided by the site.
Additional Manufacturer Narrative
Attachment: [b)(4)].
Event or Problem Description
Subsequent to the initial filed medwatch report, user facility medwatch report was received and states: describe the event or problem: stent found to be removed from the balloon when removing the stent catheter from the patient.The stent was found in the tuohy attached to the guide catheter.Stent was retrieved without any harm to patient.Patient monitored for adverse effects - no harm to patient.Whole stent was able to be removed from patient.What was the original intended procedure? : cardiac catheterization what problem did the user have (check all that apply): device failed (e.G.Broke, could not get it to work or stopped working).No additional significant 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
• MDR Report Key: 9897942
• Report Number: 3009306400-2020-00016
• Device Sequence Number: 2808600
• Product Code: MAF
• UDI-Device Identifier: 00879397000937
• UDI-Public: (01)00879397000937(17)210131(10)1801234001
• 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,Followup
• Report Date (Section B): 04/15/2020

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: 01/31/2021
• Device Model Number: 170-03-40024
• Device Catalogue Number: 170-03-40024
• Device Lot Number: 1801234001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROTATING HEMOSTATIC VALVE (RHV): TUOHY BORST.
• Patient Age: 66 YR