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

Model Number	G21369
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
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.Device evaluation: 1 x zso-8-4 of lot number cf1581651 was returned to cirl for an evaluation.It was returned in it¿s original open packaging.This investigation (b)(4) is linked to (b)(4).The investigation (b)(4) reflects the investigation into the stent that was placed in the patient and this investigation (b)(4) captures the investigation into zso-8-4 stent that was not place in the patient.Lab evaluation: 1 x zso-8-4 of lot number cf1581651 was returned to cirl for an evaluation on 14th of june 2019.In summary the following results were observed in the lab evaluation.The stent was observed to be kinked at the 02nd & 5th porthole on the tapered end.The stent was observed to be kinked and cracked at the 5th porthole on the non-tapered end.The straightener was on the returned stent.During the functional inspection a 0.035 inch wire guide pass through the stent.Document review including ifu review: prior to distribution zso-8-4 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-8-4 of lot number cf1581651 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 cf1581651.It should be noted that the instructions for use (ifu0045-6) 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.¿ root cause (possible): a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the excessive force as the stent was straightened with the straightener.It is possible that excessive force caused the stent to crack and kink.Summary: complaint is confirmed as the failure was verified in the laboratory.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.
Event or Problem Description
The pigtail curve broke off but is still attached."as per complaint form": the pigtail curve of the stents is broken but still attached.In one case they realized it already outside of the scope in the other case they realized it after implantation of the stent and decided to keep the stent in place.Please "note": nothing is detached in the body! fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.No adverse effects to the patient have been reported as occurring.
Event or Problem Description
The pigtail curve broke off but is still attached."as per complaint form": the pigtail curve of the stents is broken but still attached.In one case they realized it already outside of the scope in the other case they realized it after implantation of the stent and decided to keep the stent in place.Please not : nothing is detached in the body! fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.And 'stent kinked/bent'.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Follow up mdr is being submitted to correct the date aware provided in the initial report.

• 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: 8762500
• Report Number: 3001845648-2019-00307
• Device Sequence Number: 13850705
• Product Code: FGE
• UDI-Device Identifier: 00827002213692
• UDI-Public: (01)00827002213692(17)220131(10)CF1581651
• 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
• Report Date (Section B): 07/04/2019

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: 01/31/2022
• Device Model Number: G21369
• Device Catalogue Number: ZSO-8-4
• Device Lot Number: CF1581651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1