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

Model Number	G21462
Medical Device Problem Codes	Fracture (1260); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
There has crack on stent prior to the patient contact.They replaced a new device to finished the procedure.
Additional Manufacturer Narrative
Device evaluation: 1 x zebd-8-7of lot number cf1750622 was returned to cirl open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 02nd of april 2021.A crack was observed on the porthole on the tapered end of the stent, slight kinks were observed on the 2nd, 3rd, and 4th portholes on the tapered end, slight kinks were observed on the 2nd, 3rd, 4th, and 5th portholes on the non-tapered end of the stent.A 0.035" wireguide would not pass the kinks on the stent and the pigtail on the tapered end of the stent has relaxed where the stent is.The complaint description was mixed up with that of (b)(4) (emdr 3001845648-2021-00296).Documents review including ifu review: prior to distribution all zebd-8-7 are subjected to visual and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place in cirl.A review of the manufacturing records for zebd-7-7 for lot number cf1750622 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 cf1750622.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.
Event or Problem Description
Final mdr being submitted due to completion of investigation on 14-sept-21.There has crack on stent prior to the patient contact.They replaced a new device to finished the procedure.

• 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: 11640447
• Report Number: 3001845648-2021-00297
• Device Sequence Number: 19595375
• Product Code: FGE
• UDI-Device Identifier: 00827002214620
• UDI-Public: (01)00827002214620(17)230811(10)CF1750622
• Combination Product (Y/N): N
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 08/11/2023
• Device Model Number: G21462
• Device Catalogue Number: ZEBD-8-7
• Device Lot Number: CF1750622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 60