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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ZIMMON BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Catalog Number ZSO-7-7
Device Problems Dent in Material (2526); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
When they try to use the zso-7-7, the wire guide could not advance in to the zso-77.Did any section of the device remain inside the patient body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Were there any adverse effects on the patient due to this occurrence? no.Did the product cause or contribute to the adverse effect(s)? no.For all complaints, ask: what is the reorder number of the wire guide used with this device? the wire guide name is jag 0.035 angled tip.If not, with the device in question, how was the procedure finished? they used another zso-7-7.For complaints occurring during use (once in contact with endoscope), also ask: had a sphincterotomy been performed prior to this occurrence? yse.What is the endoscope manufacturer and model number that was used? olympus tjf260v.Please describe the location in the body where the stent was to be placed.Unknown.Was resistance encountered when advancing the wire guide through the obstructed area? no.Was resistance encountered when advancing the introduction system in place? unknown.Was resistance encountered when advancing the stent through the obstructed area? unknown.After placement, was stent position verified? unknown.If yes, please describe how.Unknown.Please estimate amount of time the stent was in place prior to this occurrence.Unknown.Did any section of the device detach inside the endoscope or patient? no.
 
Event Description
Supplemental report is being submitted due to the completion of the investigation.
 
Manufacturer Narrative
Device evaluation: 1 x zso-7-7 device of lot number c1875696 was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution all zso-7-7 devices are subject 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-7-7 of lot number c1875696 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 c1875696.It should be noted that the instructions for use (ifu0045) states the following: ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Notify cook for return authorization¿.¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent¿.There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to user technique, whereby the kinks occurred as the devices were being straightened with the straightener during loading onto wire guide.Summary: the complaint is confirmed based on customer testimony.According to the initial report, 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.
 
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Brand Name
ZIMMON BILIARY STENT
Type of Device
FGE CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
sinead o'leary
o halloran road
national technology park
limerick 
061334440
MDR Report Key13423249
MDR Text Key295956009
Report Number3001845648-2022-00052
Device Sequence Number1
Product Code FGE
UDI-Device Identifier10827002221670
UDI-Public(01)10827002221670(17)241007(10)C1875696
Combination Product (y/n)N
PMA/PMN Number
K851962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/16/2022
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
Device Operator Health Professional
Device Catalogue NumberZSO-7-7
Device Lot NumberC1875696
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/06/2022
Event Location Hospital
Initial Date Manufacturer Received 01/06/2022
Initial Date FDA Received02/02/2022
Supplement Dates Manufacturer Received01/06/2022
Supplement Dates FDA Received06/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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