MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number G48028

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿tip separation".When the nurse opened the wrapping and pressed the white bottom , the tip of the stent split opened and couldn't be used in the patient any more "as per complaint form": when the doctor open the stent, the stent was broken, before being use in the patient.".

Manufacturer Narrative

Pma/510(k) # k163468.Cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Additional information has been requested and device return expected.Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

This follow up mdr is being submitted to inform the fda that the investigation into this event is still being carried out.Additional information has been requested and device return is expected.Initial report description as follows: report submitted based on the device malfunction precedence: ¿tip separation".When the nurse opened the wrapping and pressed the white bottom , the tip of the stent split opened and couldn't be used in the patient any more."as per complaint form": when the doctor open the stent, the stent was broken, before being use in the patient.

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).Exemption number: e2016031.(b)(4).Problem statement: the customer reported the following complaint ¿when the nurse opened the wrapping and pressed the white bottom, the tip of the stent split opened and couldn't be used in the patient any more¿ ¿when the doctor open the stent, the stent was broken, before being use in the patient¿ device evaluation: the evo-25-30-8-c device of lot number c1176082 was due to return for investigation, however 3 requests were made to the customer for the device return and no update was given.The investigation will be updated if the device is received.As the device was not returned for evaluation at the time of the investigation, a document based investigation was carried out.The following additional information was received from the cook representative: 1) did the tip separate from the device? yes if so did it fall into the patient? no 2) can i confirm what is the white button? white tip 3) was the fault noticed during the procedure or prior to patient contact? prior to patient 4) was there any other damage noted on the device? no 5) can you request also if device is returning and any imaging available? no, i wiil return the device.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Engineering were contacted for their input on the possible causes of this event, and the following was stated: ¿¿i¿ve reviewed this information regarding (b)(4).The potentials may include process and design elements, however due to the numerous process controls in place that inspect the affected portion of the device, i think the most probable failure mode is "introducer tip does not remain intact".Root cause: due to the limited information available and lack of device available for evaluation, a definite root cause cannot be determined.However the following are the potential causes of this event.As stated above, the potentials may include process and design elements, however due to the numerous process controls in place that inspect the affected portion of the device it is unlikely that the device left cook ireland with the white tip broken off from the device.There is a protective tubing placed over the sheath, which is the first thing removed by the physician when using the device.It is possible that on removal of the protective tubing the physician damaged the tip of the introducer resulting in the tip separating from the device.Document review: prior to distribution all evo-25-30-8-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 (b)(4).A review of the qc records did not reveal any issues which could have contributed to this complaint issue.The following process checks are in place to inspect the white tip of the introducer: as per iqc ¿component shall be uniform and correct in colour, free of foreign materials, dirt, oil and major deformities.¿ "confirm presence of glue port¿ & ¿insert the dimpled portion of the tip component into blue portion of evolution esophageal outer sheath tubing rmn 16-030 or 16-022.If the tip falls out of the tubing under its own weight, this is deemed a failure.However if the tip doesn¿t fall out of the tubing this is deemed as a pass.¿ as per fqc: ¿inspect for visual defects; i.E.Loose or embedded foreign materials, rough or sharp edges, kinks.¿ ¿ensure that there are no sharp edges or damage to the sheath tip area." upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number.Ifu review: as per the instructions for use, 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".On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.The patient did not experience any adverse effects due to this occurrence as the issue was observed prior to patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up mdr is being submitted to include investigation details.Initial report description as follows: report submitted based on the device malfunction precedence: ¿tip separation".When the nurse opened the wrapping and pressed the white bottom, the tip of the stent split opened and couldn't be used in the patient any more "as per complaint form": when the doctor open the stent, the stent was broken, before being use in the patient.

• 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 Key: 7082748
• MDR Text Key: 94808088
• Report Number: 3001845648-2017-00580
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)171123(10)C1176082
• Combination Product (y/n): N
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2017

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 Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 12/29/2017
• Supplement Dates FDA Received: 12/29/2017; 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1