MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF EXPANDING METAL STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G50619
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Dr.(b)(6): during procedure, the outer sheath has been detached from the handle.As per complaint form: after dilatation with maxpass balloon 4 mm and 6 mm the zilver stent was introduced along a 0035 visiglide wire.During the stent release a strong resistance was encountered until complete break of the blue sheet of the stent near the handle of the stent.
Event or Problem Description
Dr.Bertani during procedure, the outer sheath has been detached from the handle "as per complaint form":after diltation with maxpass ballon 4 mm and 6 mm the zilver stent was introduced along a 0035 visiglide wire.During the stent release a strong resistance was encountered until complete break of the blue sheet of the stent near the handle of the stent.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor breaking during deployment (incl.Flexor/handle separation)'.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031 information pertaining to as follows: importer site contact and address: (b)(6).Importer site establishment registration number: 3005580113 device evaluation the zilbs-635-6-6 device of lot number c1454944 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The investigation will be updated once the device has been returned and evaluated.Lab evaluation ¿ n/a.Document review including ifu review prior to distribution zilbs-635-6-6 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 zilbs-635-6-6 of lot number c1454944 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1454944.There is no evidence to suggest that the customer did not follow the instructions for use.Image review ¿ n/a.Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.It is possible that a slightly difficult patient anatomy may have caused and/or contributed to resistance during advancement and/or deployment.Resistance during deployment could have resulted in high forces on the flexor (outer sheath) during deployment causing the flexor to become separated from the handle.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Dr.(b)(6) during procedure, the outer sheath has been detached from the handle."as per complaint form":after dilation with maxpass balloon 4 mm and 6 mm the silver stent was introduced along a 0035 visiglide wire.During the stent release a strong resistance was encountered until complete break of the blue sheet of the stent near the handle of the stent.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor breaking during deployment (incl.Flexor/handle separation)'.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(6).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
(b)(6) during procedure, the outer sheath has been detached from the handle "as per complaint form":after diltation with maxpass ballon 4 mm and 6 mm the zilver stent was introduced along a 0035 visiglide wire.During the stent release a strong resistance was encountered until complete break of the blue sheet of the stent near the handle of the stent.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor breaking during deployment (incl.Flexor/handle separation)'.No adverse effects to the patient have been reported as occurring.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8373164
• Report Number: 3001845648-2019-00079
• Device Sequence Number: 11355317
• Product Code: FGE
• UDI-Device Identifier: 10827002506197
• UDI-Public: (01)10827002506197(17)210219(10)C1454944
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K020788
• 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,Followup,Followup
• Report Date (Section B): 04/25/2019

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: 02/19/2021
• Device Model Number: G50619
• Device Catalogue Number: ZILBS-635-6-6
• Device Lot Number: C1454944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 01/30/2019; 01/30/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/27/2019; 04/25/2019; 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 70