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

Model Number	170-03-40018
Medical Device Problem Codes	Unstable (1667); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received 22-nov-2019.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 was tightly folded, indicating that no inflation or deployment attempts were made; guidewire notch and stent struts were noted to be damaged; stent was shifted distally past the delivery system's distal tip,.Applicable dimensional analysis on the returned device met product specifications.Functional analysis was not performed due to the condition of the returned device.Complaints specialist was unable to replicate inability to cross 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 visual inspection of the stent and for stent retention.Risk assessment review indicates that advancement difficulty, stent damage, and loose / shifted stent are captured as a known potential hazard.Investigation is not yet complete.A follow-up report with additional relevant information will be submitted.
Event or Problem Description
On (b)(6) 2019, a (b)(6)-year old female patient with st-elevated myocardial infarction (stemi) presented for planned percutaneous coronary intervention (pci) of an unknown vessel.After pre-dilatation, a 4.0x18mm cobra pzf¿ coronary stent system was advanced toward the target lesion but unable to cross.A 3.5 x 16mm synergy stent was then placed at the target lesion.There were no adverse patient effects reported.The device was received 22-nov-2019 with extensive damage to the stent, with the stent was stretched and shifted distally past the distal tip of the delivery system, but not completely dislodged.Additional information was requested from the site.

• 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: 9473188
• Report Number: 3009306400-2019-00068
• Device Sequence Number: 19510140
• Product Code: MAF
• UDI-Device Identifier: 00879397000920
• UDI-Public: (01)00879397000920(17)200930(10)1709064004
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/16/2019

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: 170-03-40018
• Device Catalogue Number: 170-03-40018
• Device Lot Number: 1709064004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR