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

Model Number	170-03-40030
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received 22-jul-2019.Returned device analysis begun on 25-jul-2019 revealed that the stent was not returned with the balloon.Complaints specialist performed visual analysis on the returned delivery system.Complaints specialist received the delivery system in the following condition: the stent is missing (was not returned with device).The balloon is tightly folded, indicating that no inflation or deployment attempts were made.Stent crimp (pillow) marks are present, confirming stent was previously crimped to balloon.Functional analysis for the reported stent shifting on balloon was unable to be performed due to the condition of the returned device, as it was received without its stent.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 stent retention.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.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
A (b)(6)-year-old male patient presented with st-elevated myocardial infarction (nstemi); treatment of an unspecified vessel via percutaneous coronary intervention (pci) was scheduled.On (b)(6) 2019, after unpackaging a 4.0x30mm cobra pzf¿ nanocoated coronary stent system, the stent appeared to be shifted proximally on the balloon, but was not dislodged.The device was not used in the patient; it was re-packaged by the site for return.Celonova biosciences returned goods lab received the device without its stent.Additional information received indicates that the site thought the stent had been repackaged with its delivery system and, while the current stent location is not known, the device was never used in the patient.No additional information as 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: 8910644
• Report Number: 3009306400-2019-00042
• Device Sequence Number: 372059
• Product Code: MAF
• UDI-Device Identifier: 00879397000944
• UDI-Public: (01)00879397000944(17)210531(10)1805164004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: 05/31/2021
• Device Model Number: 170-03-40030
• Device Catalogue Number: 170-03-40030
• Device Lot Number: 1805164004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR