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

Catalog Number	170-03-40018
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	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received; analysis is not yet complete.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.Stent damage and dislodgement are captured in the risk assessment as known potential hazards.Investigation is not yet complete.A follow-up report with relevant additional information will be submitted.
Event or Problem Description
On (b)(6) 2018, prior to removing a 4.0x18mm cobra pzf nanocoated coronary stent system from its dispenser coil packaging, the coil was flushed with heparinized saline.The stent system was then pulled out of the coil without difficulty.Negative pressure, with contrast, was then drawn using an indeflator inflation device, followed by removal of the protective stent sheath, without issue.The stent system was then advanced in the patient via radial access; once crossing the lesion, an attempt was made to deploy the stent, but it was discovered that the stent had dislodged onto the proximal shaft at some point during advancement.All devices (stent, delivery system, guide catheter, and guide wire) were then withdrawn as a single unit.The flared stent ends were then noted and, reportedly, the flared ends likely occurred during advancement then withdrawal.There were no adverse patient effects.The patient was successfully treated with a drug-eluting stent.Though requested, 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: 8261395
• Report Number: 3009306400-2018-00089
• Device Sequence Number: 19221644
• Product Code: MAF
• UDI-Device Identifier: 00879397000678
• UDI-Public: (01)00879397000678(17)201130(10)1711024001
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: 160014
• 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): 01/18/2019

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: 11/30/2020
• Device Catalogue Number: 170-03-40018
• Device Lot Number: 1711024001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1