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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE CATHETER, BILIARY, DIAGNOSTIC

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COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Catalog Number OACL-10-7
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
The stent was not easy to move into biliary.
 
Manufacturer Narrative
Device evaluation: 1 x oacl-10-7 of lot number c1756752 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 07 dec 2022.The returned device lab examination findings and observations can be referred through attached files.On evaluation of the device, it was noted that the pushing catheter, introducer, positioning sleeve and stent returned.Slight kink observed on pushing catheter approximately 40 cm from the hub.No damage observed on the stent.Stent moves freely over the introducer.0.035-inch wire guide passes through the stent.Document review: prior to distribution all oacl -7-5 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 oacl-7-5 of lot number c1756752 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 ¿c1756752¿.The instructions for use, ifu0096-1 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.¿ there is no evidence to suggest the user did not follow the ifu.Root cause review: 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 difficult patient anatomy leading to difficulty advancing and placing the device.Multiple attempts have been made and no additional information has been obtained if more information does become available at a later date, the file will be reopened and re investigated.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated 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 Description
This supplemental report is being submitted due to completion of the investigation on 03-mar-2023.
 
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Brand Name
OASIS ONE ACTION STENT INTRODUCTION SYSTEM
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 
MDR Report Key16003262
MDR Text Key308558212
Report Number3001845648-2022-00884
Device Sequence Number1
Product Code FGE
UDI-Device Identifier10827002253800
UDI-Public(01)10827002253800(17)230904(10)C1756752
Combination Product (y/n)N
Reporter Country CodeTW
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 03/03/2023
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 Expiration Date09/04/2023
Device Catalogue NumberOACL-10-7
Device Lot NumberC1756752
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/18/2022
Event Location Hospital
Initial Date Manufacturer Received 11/23/2022
Initial Date FDA Received12/19/2022
Supplement Dates Manufacturer Received11/23/2022
Supplement Dates FDA Received03/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
Patient SexMale
Patient Weight65 KG
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