MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number CST-10

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

This event is currently being investigated.A follow up report will be submitted with the investigation conclusions.This event is currently being investigated.A follow up report will be submitted with the investigation conclusions.

Event Description

It was reported that the customer has had huge difficulties with cystotome.He said the main problem is that he cannot separate catheter when placing the stent in patient.Using the cystotome: placing the inner catch first and burning small hole(1) then pressing the outer catheter 10 fr over the inner and burning 2nd time(2) - then usually you retract the inner-catch because you want to place a stent in the hole to drain the cyst - if you do not place a stent the patient has a hole that clots and will not get drain for the bacterial fluid.In these cases(all 3) it was not possible to retract the inner-catch - it was stuck - and they had to pull every tool out and finish all procedures at operating room.It was confirmed that there was a delay in the procedure as a result of the device failure.The patient required surgery in the operating room to complete the procedure with another device.The customer has used the cystotome for 15 years and are quite skilled using it.This is the 3rd time in 2 weeks.Reference also related report# 3001845648-2016-00371 and report# 3001845648-2016-00373.

Manufacturer Narrative

The device involved in this complaint was returned to cirl and a lab evaluation was completed.During the lab evaluation the cst-10 device was found to be damaged.The inner catheter was broken in two places with one part remaining inside the outer catheter.The two pieces of inner catheter totalled 228cm in length which indicates stretching of approximately 18cm.The outer catheter was badly kinked and twisted adjacent to the shrink tube - it was noted that this could possibly be at the point of contact with the scope during use.The kink was straightened during the lab evaluation and the inner catheter was able to be removed with ease.The stretching, kinking and breakages are indicative of the use of excessive force.The inner catheter was found detached from the t-fitting with the flare on the catheter pulled right through.The engineer mentioned that the flare is checked by the manufacturing team member during production.Continuity was checked and found to be ok.The engineer stated that this could potentially be patient related but further input from product management was sought.The customer complaint was confirmed based on customer testimony and visual inspection of the damaged device which suggests excessive force applied due to removal difficulty.Input from product management suggests that the customer did not follow the sequence in the ifu which could have contributed to the event ¿when the complaint says ¿it is stocked in all 3 cases ¿ so that he is not able to place a stent over a wire in the same procedure¿.I think it is referring to the 5fr catheter being stuck within the 10fr catheter not the wire being stuck.From the complaint details it seems to read as if both the initial cut using the needle knife and the second cut using the 10fr diathermic ring had been completed, but not per the ifu.The method outlined in the ifu to achieve both cuts is to push the 10 fr catheter while slightly pulling back the inner 5fr catheter (which requires partial separation of the two) after the first cut and before the second cut and also to introduce a wire guide during this time also.It does not appear this was done.¿when using the cystotome the doctor (per ejstrud) first push the inner catheter into the cyst (using xray as view) burn(1) the first hole in which he pushes the outer catheter into to burn again(2) to make the hole fit to 10 fr plastic stent¿ the easiest way to introduce a wire guide is to remove ¿proximal electrode (part a) which is attached to the needle knife¿ per the ifu and introduce the wire guide through the 5fr inner catheter.If a wire guide is in place there should be no reason to try to disconnect the 5fr sheath from the 10fr sheath¿.A potential root cause of this difficult removal complaint could be attributed to patient anatomy or possibly user error- if the customer did not follow the optimum usage of the device as per the ifu.A review of the manufacturing records for lot c1269641 did not reveal any discrepancies that could have contributed to this occurrence.Upon review of complaints, this failure mode has occurred previously with this lot number; there have been three complaints issued from the same customer for the same issue.However, based on the information provided to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1269641 as there have been no other events outside of the three related events involved in this complaint.Prior to distribution, all cst-10 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per procedure all products and packaging are 100% inspected for visual irregularities such as holes, dents, kinks or tears.Cst-10 devices are final product quality controlled (fqc¿d); there is a check on each device to; ¿inspect for visual defects i.E.Loose or embedded foreign materials, rough or sharp edges, kinks, smoothness of tips.¿ and also to ¿check the continuity from the contact pin on the outer catheter sub assembly to the diathermic ring.¿ a review of the manufacturing records for cst-10 devices of lot# c1269641 did not reveal any discrepancies that could have contributed to this complaint issue.The instructions for use that accompany this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Complaints of this nature will continue to be monitored for potential emerging trends.The device involved in this complaint was returned to cirl and a lab evaluation was completed.During the lab evaluation, the cst-10 device was found to be damaged.The inner catheter was broken in two places with one part remaining inside the outer catheter.The two pieces of inner catheter totalled 228cm in length which indicates stretching of approximately 18cm.The outer catheter was badly kinked and twisted adjacent to the shrink tube - it was noted that this could possibly be at the point of contact with the scope during use.The kink was straightened during the lab evaluation and the inner catheter was able to be removed with ease.The stretching, kinking and breakages are indicative of the use of excessive force.The inner catheter was found detached from the t-fitting with the flare on the catheter pulled right through.The engineer mentioned that the flare is checked by the manufacturing team member during production.Continuity was checked and found to be ok.The engineer stated that this could potentially be patient related but further input from product management was sought.The customer complaint was confirmed based on customer testimony and visual inspection of the damaged device which suggests excessive force applied due to removal difficulty.Input from product management suggests that the customer did not follow the sequence in the ifu which could have contributed to the event ¿when the complaint says ¿it is stocked in all 3 cases ¿ so that he is not able to place a stent over a wire in the same procedure¿.I think it is referring to the 5fr catheter being stuck within the 10fr catheter not the wire being stuck.From the complaint details it seems to read as if both the initial cut using the needle knife and the second cut using the 10fr diathermic ring had been completed, but not per the ifu.The method outlined in the ifu to achieve both cuts is to push the 10 fr catheter while slightly pulling back the inner 5fr catheter (which requires partial separation of the two) after the first cut and before the second cut and also to introduce a wire guide during this time also.It does not appear this was done.¿when using the cystotome the doctor (per ejstrud) first push the inner catheter into the cyst (using xray as view) burn(1) the first hole in which he pushes the outer catheter into to burn again(2) to make the hole fit to 10 fr plastic stent¿ the easiest way to introduce a wire guide is to remove ¿proximal electrode (part a) which is attached to the needle knife¿ per the ifu and introduce the wire guide through the 5fr inner catheter.If a wire guide is in place there should be no reason to try to disconnect the 5fr sheath from the 10fr sheath¿.A potential root cause of this difficult removal complaint could be attributed to patient anatomy or possibly user error- if the customer did not follow the optimum usage of the device as per the ifu.A review of the manufacturing records for lot c1269641 did not reveal any discrepancies that could have contributed to this occurrence.Upon review of complaints, this failure mode has occurred previously with this lot number; there have been three complaints issued from the same customer for the same issue.However, based on the information provided to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1269641 as there have been no other events outside of the three related events involved in this complaint.Prior to distribution, all cst-10 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per procedure all products and packaging are 100% inspected for visual irregularities such as holes, dents, kinks or tears.Cst-10 devices are final product quality controlled (fqc¿d); there is a check on each device to; ¿inspect for visual defects i.E.Loose or embedded foreign materials, rough or sharp edges, kinks, smoothness of tips.¿ and also to ¿check the continuity from the contact pin on the outer catheter sub assembly to the diathermic ring.¿ a review of the manufacturing records for cst-10 devices of lot# c1269641 did not reveal any discrepancies that could have contributed to this complaint issue.The instructions for use that accompany this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This is a follow up report following the completion of the investigation.It was reported that the customer has had huge difficulties with cystotome.He said the main problem is that he cannot separate catheter when placing the stent in patient.Using the cystotome: placing the inner catch first and burning small hole(1) then pressing the outer catheter 10 fr over the inner and burning 2nd time(2) - then usually you retract the inner-catch because you want to place a stent in the hole to drain the cyst - if you do not place a stent, the patient has a hole that clots and will not get drain for the bacterial fluid.In these cases(all 3) it was not possible to retract the inner-catch - it was stuck - and they had to pull every tool out and finish all procedures at or.It was confirmed that there was a delay in the procedure as a result of the device failure.The patient required surgery in the or to complete the procedure with another device.The customer has used the cystotome for 15 years and are quite skilled using it.This is the 3rd time in 2 weeks.Reference also related report# 3001845648-2016-00371 and report# 3001845648-2016-00373.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6188418
• MDR Text Key: 62799279
• Report Number: 3001845648-2016-00372
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)190908(10)C1269641
• Combination Product (y/n): N
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2016
• Event Location: Hospital
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1