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

Model Number	G21707
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is underway.
Event or Problem Description
Before using this product for procedure, the side hole of this product pigtail was kink.They couldn't pass the wire guide in to the zso.
Additional Manufacturer Narrative
1 x zso-7-10 device of lot number c1642274 was returned to cirl for evaluation opened with its original packaging.No straightener was returned, no visual kinks on pigtails.No defect was observed.Prior to distribution zso-7-10 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zso-7-10 of lot # c1642274 did not reveal any discrepancies that could have contributed to this complaint issue.It should be noted that the instructions for use states the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use.¿ ¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent.¿ it may be noted the device label indicates a 0.035¿ wire guide for use with this device there is evidence to suggest that the user did not follow the instructions for use.A definitive root cause can be attributed to the use of a non-recommended wire guide with the device.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As the smaller diameter 0.025¿ wire guide occupies less space in the lumen of the pigtail stent it is likely that the extent of the curvature of the pigtail will be greater when a 0.025¿ wire guide is used.As per additional information received a 0.025" wire guide was used.The customer¿s testimony could not be confirmed however the complaint is confirmed based on the failure verified in the investigation.The device did not make patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Before using this product for procedure, the side hole of this product pigtail was kink.They couldn't pass the wire guide in to the zso.
Event or Problem Description
Before using this product for procedure, the side hole of this product pigtail was kink.They couldn't pass the wire guide in to the zso.
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: ZIMMON BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9647396
• Report Number: 3001845648-2020-00067
• Device Sequence Number: 501859
• Product Code: FGE
• UDI-Device Identifier: 00827002217072
• UDI-Public: (01)00827002217072(17)220817(10)C1642274
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2020

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: 08/17/2022
• Device Model Number: G21707
• Device Catalogue Number: ZSO-7-10
• Device Lot Number: C1642274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/23/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/05/2020
• Supplement Date Received by Manufacturer: 01/05/2020; 01/05/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/27/2020; 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1