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

Model Number	G25794
Medical Device Problem Codes	Dent in Material (2526); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
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
The device was used for ebd treating obstructive jaundice.When the user advanced the stent over the wire guide, it became kinked near the distal tip of the wire guide.The strainer was used.Another manufacturer's device was used instead.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/ bent'.
Event or Problem Description
The device was used for ebd treating obstructive jaundice.When the user advanced the stent over the wire guide, it became kinked near the distal tip of the wire guide.The strainer was used.Another manufacturer's device was used instead.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/ bent'.
Additional Manufacturer Narrative
Device evaluation: 1 x zebd-7-10 of lot c1653051 number was returned to cirl open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 10th of january 2020.A kinks were noted at the 2nd, 3rd & 5th portholes on the tapered end on the pigtail.Kinks were noted on the 2nd & 3rd porthole of the non-tapered end of the pigtail.A 0.035" wire guide does not pass the kinks.Image review: n/a.Documents review including ifu review: prior to distribution all zebd-7-10 are subjected to visual and functional checks to ensure device integrity.A review of the manufacturing records for zebd-7-10 of lot number c1653051 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 c1653051.The instructions for use, ifu0045-7 which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ also, the user is instructed by the instructions for use, ifu0045-7: ¿care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent.¿ there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory and due to limited information.A possible cause of this complaint may be that the kink occurred while being straightened as it was being loaded onto the wire guide.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the information reported, 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
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The device was used for ebd treating obstructive jaundice.When the user advanced the stent over the wire guide, it became kinked near the distal tip of the wire guide.The strainer was used.Another manufacturer's device was used instead. the device was used for ebd treating obstructive jaundice.When the user advanced the stent over the wire guide, it became kinked near the proximal tip of the wire guide.The strainer was used.Another manufacturer's device was used instead.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/ bent'.
Event or Problem Description
The device was used for ebd treating obstructive jaundice.When the user advanced the stent over the wire guide, it became kinked near the distal tip of the wire guide.The strainer was used.Another manufacturer's device was used instead.
Additional Manufacturer Narrative
Device evaluation: 1 x zebd-7-10 of lot c1653051 number was returned to cirl open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 10th of january 2020.A kinks were noted at the 2nd, 3rd & 5th portholes on the tapered end on the pigtail.Kinks were noted on the 2nd & 3rd porthole of the non-tapered end of the pigtail.A 0.035" wire guide does not pass the kinks.Image review: n/a.Documents review including ifu review: prior to distribution all zebd-7-10 are subjected to visual and functional checks to ensure device integrity.A review of the manufacturing records for zebd-7-10 of lot number c1653051 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 c1653051.The instructions for use, ifu0045-7 which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ also, the user is instructed by the instructions for use, ifu0045-7: ¿care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent.¿ there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory and due to limited information.A possible cause of this complaint may be that the kink occurred while being straightened as it was being loaded onto the wire guide.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the information reported, 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.

• Brand Name: ZIMMON BILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9472532
• Report Number: 3001845648-2019-00718
• Device Sequence Number: 11451058
• Product Code: FGE
• UDI-Device Identifier: 00827002257948
• UDI-Public: (01)00827002257948(17)220923(10)C1653051
• 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,Followup,Followup
• Report Date (Section B): 02/04/2020

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: 09/23/2022
• Device Model Number: G25794
• Device Catalogue Number: ZEBD-7-10
• Device Lot Number: C1653051
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/07/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 11/21/2019; 11/21/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/14/2020; 02/12/2020; 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1