MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON BILIARY STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G21396
Medical Device Problem Codes	Material Deformation (2976); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of stent kinked/bent.A kink was confirmed upon opening the packaging of the device, so it was replaced with another zebd-7-7 (lot unknown) and the procedure was completed successfully.
Event or Problem Description
This report is being submitted as a cancellation report.Based on limited initial information, the event was assessed cautiously as reportable based on the fda reporting precedence for "stent kinked/bent".Following device evaluation it has been confirmed that this malfunction has not occurred.No adverse effects to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.The device has been evaluated and no defect was observed- this device was not used on a patient.A kink was confirmed upon opening the packaging of the device, so it was replaced with another zebd-7-7 (lot: unknown) and the procedure was completed successfully.
Additional Manufacturer Narrative
This report is being submitted as a cancellation report.Based on limited initial information, the event was assessed cautiously as reportable based on the fda reporting precedence for "stent kinked/bent".Following device evaluation it has been confirmed that a device malfunction has not occurred.No adverse effects to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.The device has been evaluated and no defect was observed this device was not used on a patient.

• Brand Name: ZIMMON BILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9102717
• Report Number: 3001845648-2019-00482
• Device Sequence Number: 2062588
• Product Code: FGE
• UDI-Device Identifier: 00827002213968
• UDI-Public: (01)00827002213968(17)220528(10)C1618272
• Combination Product (Y/N): N
• PMA/510(K) Number: K851962
• 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): 09/23/2019

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: 05/28/2022
• Device Model Number: G21396
• Device Catalogue Number: ZEBD-7-7
• Device Lot Number: C1618272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1