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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE
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COOK IRELAND LTD EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE Back to Search Results
Model Number G48038
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2020
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k)#: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
User advanced the device to desired position and then pressed the release button to deploy the stent but found the stent cannot be released.User also detected the proximal end of sheath broken.User retracted the device and changed another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Pma/510(k)#: k163468.Device evaluation: the evo-25-30-10-c device of lot number c1588547 involved in this complaint device involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2020.In summary the following results were observed in the lab evaluation: flexor was observed broken at the clear section.Handle was actuating fine.Unable to release the stent due of damage on clear section of flexor.Following the lab evaluation additional information was requested to aid with the investigation: can they provide a more accurate location within the colon that the issue occurred please? what is the clear light film of plastic stuck in break point? is it from the packaging the device was returned in? one attempt for additional information has been made deviation.It may be noted, that the clear light film of plastic stuck in break point is most likely not a production issue.Documents review including ifu review: prior to distribution all evo-25-30-10-c 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 evo-25-30-10-c device of lot number c1588547 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1588547; upon review of complaints this failure mode has not occurred previously with this lot #c1588547.The instructions for use ifu0052-10 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to patient anatomy or device handling.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
User advanced the device to desired position and then pressed the release button to deploy the stent but found the stent cannot be released.User also detected the proximal end of sheath broken.User retracted the device and changed another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." patient outcome: "a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." patient/event info - notes: what is the reorder number of the wire guide used with this device? metii-35-480.If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with patient) also ask: what is the endoscope manufacturer and model number that was used during the procedure? olympus cf-hq290i.Had dilation of the stricture been performed prior to stent placement? no.What was the diameter of the stricture at the time of stent placement (in mm)? 1.3 cm.What was the length of the stricture at the time of stent placement (in cm)? 5 cm.Please describe the location in the body where the stent was to be placed.Colon.Was resistance encountered when advancing the wire guide through the stricture? no.Was resistance encountered when advancing the introducer and stent into position? no.Did any section of the device detach inside the patient? no.After placement, was stent position verified? if yes, please describe how.N/a.After placement, was the endoscope advanced through the stent? n/a.Please estimate amount of time the stent was in place prior to this occurrence.N/a.Did the patient undergo chemotherapy or radiation treatments after stent placement? n/a.
 
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Brand Name
EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
Type of Device
MQR STENT, COLONIC METALLIC EXPANDABLE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10016904
MDR Text Key221586362
Report Number3001845648-2020-00273
Device Sequence Number1
Product Code MQR
UDI-Device Identifier10827002480381
UDI-Public(01)10827002480381(17)210222(10)C1588547
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/22/2021
Device Model NumberG48038
Device Catalogue NumberEVO-25-30-10-C
Device Lot NumberC1588547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/09/2020
Event Location Hospital
Date Manufacturer Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
Patient Weight63
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