MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Model Number G34111

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The transparent sheath is kicked resulting the stent cannot be deployed.Then, physician decided to use a new stent set, finally the case successes.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The transparent sheath is kicked resulting the stent cannot be deployed.Then, physician decided to use a new stent set, finally the case successes.

Manufacturer Narrative

Device evaluation: the evo-fc-10-11-8-b device of lot number c1393888 was not available for evaluation.With the information provided a document based investigation was carried out.The patient had the following pre-existing conditions: biliary stricture.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.The following additional information was provided: 1.Was the directional button fully engaged? i believe so.2.Did the red cursor move when the trigger was pressed? not known.3.Did the red cursor continue to move after the delivery stopped? na.4.Was the stent partially deployed? no 5.If the stent was partially exposed, was it possible to retract it fully before removal? na.6.Were any additional procedures needed? no.Root cause: based on the information provided and engineering input, the most likely root cause of this event was that the possible kink that they think may have occurred at some stage during the procedure caused a build-up of pressure and resulted in the flexor breaking ("crunch" sound heard).Document review: prior to distribution all evo-fc-10-11-8-b 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 qc record did not reveal any issues which could have contributed to this complaint issue.A review of the manufacturing records for evo-fc-10-11-8-b device of lot number c1393888 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 # c1393888; upon review of complaints this failure mode has not occurred previously with this lot # c1393888.Ifu review: as per the instructions for use, notes section the user is instructed of 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".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.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Report is being submitted as it meets the criteria of an fda ¿¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.The transparent sheath is kicked resulting the stent cannot be deployed.Then, physican decided to use a new stent set, finally the case successes.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7472094
• MDR Text Key: 107461302
• Report Number: 3001845648-2018-00192
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)190725(10)C1255051
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• 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: 04/30/2018

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 Date: 07/25/2019
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1255051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 04/04/2018
• Supplement Dates FDA Received: 05/28/2018; 06/25/2018
• Patient Sequence Number: 1