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

Model Number	G22163
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
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 pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The bile duct was cannulated routinely however the customer was unable to push the guide wire through the stent in order to mount it on the wire.The stent could not be mounted in the wire guide.
Additional Manufacturer Narrative
(b)(4).Problem statement: the customer reported the following complaint issue: as per cc form: "the bile duct was cannulated routinely however the customer was unable to push the guide wire through the stent in order to mount it on the wire.The stent could not be mounted in the wire guide.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence".1 x zso-7-5 of lot # c1390264 was returned to (b)(4) for evaluation.Lab evaluation: a lab evaluation was held on 11th jan 2018.On evaluation of the returned device, a 0.035 inch wire guide successfully passed through stent lumen with no resistance.There was an indentation noted at porthole 2 at the duodenal end.There was no side or back wall damage.No other defects were observed.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.A possible root cause may be that the stent became damaged while straightening pigtails.It may be noted that the stent would not have left the manufacturing facility in a damaged state.The complaint is confirmed as the failure was verified in the laboratory and the stent was found to be damaged.Documents review: a review of the manufacturing records for the device of lot # c1390264 did not reveal any discrepancy related to the complaint issue.Prd/fqc/pkg review: there is 100% inspection on all stents for kinks and a check that the appropriate size wire guide moves smoothly and freely when inserted into both ends of the stent.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc "complete a 100% visual inspection of the packaged unit (tyvek pouched) while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions." prior to distribution, all zso devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).Ifu review: it may be noted that according to the instructions for use, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.Summary: the complaint is confirmed as the failure was verified in the laboratory and the stent was found to be damaged.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up mdr is being submitted to update the investigation conclusions.The bile duct was cannulated routinely however the customer was unable to push the guide wire through the stent in order to mount it on the wire.The stent could not be mounted in the wire guide.
Event or Problem Description
This follow up mdr is being submitted to update the investigation conclusions.The bile duct was cannulated routinely however the customer was unable to push the guide wire through the stent in order to mount it on the wire.The stent could not be mounted in the wire guide.
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.Problem statement: the customer reported the following complaint issue: as per cc form: "the bile duct was cannulated routinely however the customer was unable to push the guide wire through the stent in order to mount it on the wire.The stent could not be mounted in the wire guide.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence".1 x zso-7-5 of lot # c1390264 was returned to cirl for evaluation lab evaluation: a lab evaluation was held on 11th jan 2018.On evaluation of the returned device, a 0.035 inch wire guide successfully passed through stent lumen with no resistance.There was an indentation noted at porthole 2 at the duodenal end.There was no side or back wall damage.No other defects were observed.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.A possible root cause may be that the stent became damaged while straightening pigtails.It may be noted that the stent would not have left the manufacturing facility in a damaged state.The complaint is confirmed as the failure was verified in the laboratory and the stent was found to be damaged.Documents review: a review of the manufacturing records for the device of lot # c1390264 did not reveal any discrepancy related to the complaint issue.Prd/fqc/pkg review: there is 100% inspection on all stents for kinks and a check that the appropriate size wire guide moves smoothly and freely when inserted into both ends of the stent.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc "complete a 100% visual inspection of the packaged unit (tyvek pouched) while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions." prior to distribution, all zso devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Ifu review: it may be noted that according to the instructions for use, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.Summary: the complaint is confirmed as the failure was verified in the laboratory and the stent was found to be damaged.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 7153790
• Report Number: 3001845648-2017-00602
• Device Sequence Number: 13814835
• Product Code: FGE
• UDI-Device Identifier: 00827002221635
• UDI-Public: (01)00827002221635(17)200817(10)C1390264
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2017

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: Lay User/Patient
• Device Model Number: G22163
• Device Catalogue Number: ZSO-7-5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1