MAUDE Adverse Event Report: MEDINOL LTD. NIRXCELL COCR CORONARY STENT ON RX SYSTEM; STENT, CORONARY

Model Number	4.0X12
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet returned to the manufacturer.
Event or Problem Description
Initial information: the tech had difficulty getting the stylet off the system.Once he took the stylet off, he inspected the system and saw that the stent was partially dislodged from the balloon.This was information given by another party.There was no patient injury.Additional information on may 18, 2017: nirxcell was handled and prepped according to the instructions for use.Both the doctor and the tech tried to remove the shipping mandrel stating that the metal eye was under the plastic and it was very difficult to remove.The stent was not manipulated after removing the protective sleeve with shipping mandrel.

• Brand Name: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 6610446
• Report Number: 3003084171-2017-00012
• Device Sequence Number: 7106
• Product Code: MAF
• UDI-Device Identifier: 07290107011013
• UDI-Public: 07290107011013
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2017

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: Medical Technologist
• Device Expiration Date: 06/30/2017
• Device Model Number: 4.0X12
• Device Catalogue Number: NXL40012US
• Device Lot Number: NUS00198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1