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

Model Number	G22983
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
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.Doctor wanted to insert the zso-7-17 in the cbd.So the nurse prepared the zso-7-7, but the pigtail section was bent as she moved the stent sleeve to the pigtail section.She tried to pass the guide wire into the zso-7-7, it was impossible, so they used the new one.
Additional Manufacturer Narrative
This report is being submitted as a cancellation report.Initial information indicated that the device involved in the event was a zso-7-15 (biliary stent).However, it's been confirmed that the device was a spsof-7-15 (pancreatic stent).No reporting precedence is in place for the malfunction in this event for this product family.The event does not meet the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Risk for this malfunction has been assessed as low.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.
Event or Problem Description
This report is being submitted as a cancellation report.Initial information indicated that the device was a zso-7-15.However, it's been confirmed that the device was a spsof-7-15.No reporting precedence is in place for the malfunction in this event for this product family.The event does not meet the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Risk for this malfunction has been assessed as low.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of stent kinked/bent.Doctor wanted to insert the zso-7-17 in the cbd.So the nurse prepared the zso-7-7, but the pigtail section was bent as she moved the stent sleeve to the pigtail section.She tried to pass the giuide wire into the zso-7-7, it was impossible, so they used the new one.

• Brand Name: ZIMMON BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9102695
• Report Number: 3001845648-2019-00481
• Device Sequence Number: 13915546
• Product Code: FGE
• UDI-Device Identifier: 00827002229839
• UDI-Public: (01)00827002229839(17)210502(10)C1481172
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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: 05/02/2021
• Device Model Number: G22983
• Device Catalogue Number: ZSO-7-15
• Device Lot Number: C1481172
• 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: 08/26/2019
• 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: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1