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

Catalog Number CST-10

Device Problems Difficult to Advance (2920); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); Not Applicable (3189)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

The cst-10 device involved in this complaint is of lot number c802049.The cst-10 device involved in this complaint was not returned for evaluation.With the information provided a document based investigation was carried out.As the device involved in this complaint was not returned for evaluation and conditions of use cannot be replicated in a laboratory setting it is not possible to conclusively determine a root cause for this complaint.A review of the manufacturing records for this cst-10 device of lot number c802049 did not reveal any discrepancies that would lead to this complaint the cst-10 cystotome device consists of a proximal electrode, a distal electrode, a diathermic ring, a needle knife, an inner catheter and an outer catheter.The components involved in this complaint are the inner catheter and an outer catheter.A review of manufacturing records of these components did not reveal any discrepancies that could relate to the complaint.The instructions for use, states prior to use to."visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use".In the precaution section of the ifu it states ¿refer to package label for minimum channel size required for this device ¿ the following note is also included in the instructions for use for this device, "before each introduction of a wire guide into a device, wet wire guide in a sterile water or saline bath.A contrast filled catheter may make wire guide difficult to advance.Flush contrast from catheter with sterile water or saline before each introduction of wire guide.Advance wire guide into pancreatic pseudocyst to facilitate the introduction of a stent or drainage set".Prior to distribution, all cst-10 devices are subjected to functional checks and visual inspection outlined in cirl internal procedures to ensure integrity of the product.The complaint was confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.The cst-10 device involved in this complaint was not returned for evaluation.With the information provided a document based investigation was carried out.As the device involved in this complaint was not returned for evaluation and conditions of use cannot be replicated in a laboratory setting it is not possible to conclusively determine a root cause for this complaint.A review of the manufacturing records for this cst-10 device of lot number c802049 did not reveal any discrepancies that would lead to this complaint the cst-10 cystotome device consists of a proximal electrode, a distal electrode, a diathermic ring, a needle knife, an inner catheter and an outer catheter.The components involved in this complaint are the inner catheter and an outer catheter.A review of manufacturing records of these components did not reveal any discrepancies that could relate to the complaint.The instructions for use, states prior to use to."visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use".In the precaution section of the ifu it states ¿refer to package label for minimum channel size required for this device ¿ the following note is also included in the instructions for use for this device, "before each introduction of a wire guide into a device, wet wire guide in a sterile water or saline bath.A contrast filled catheter may make wire guide difficult to advance.Flush contrast from catheter with sterile water or saline before each introduction of wire guide.Advance wire guide into pancreatic pseudocyst to facilitate the introduction of a stent or drainage set".Prior to distribution, all cst-10 devices are subjected to functional checks and visual inspection outlined in cirl internal procedures to ensure integrity of the product.The complaint was confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The event information received indicated the outer catheter of the cystome (cst-10) device would not pass through the end of scope.The outer ring of the device did not move on the inner catheter to enlarge the initial puncture site.The user has indicated the bleed was caused as a result of trying to force the outer ring of the cst device down to dilate the puncture site up.The device is not being returned due to the fact that the patient has mrsa.No additional information has been received to date to indicate the extent of the bleeding or if any additional procedures were carried out as a result of the bleed.For purposes of this reporting assessment it will be assumed the bleed was sufficient to meet the criteria of a 'serious injury' as per fda cfr regulations.It is noted that this device is not a dilation device.Adopting a conservative approach a user error related 'serious injury' report is being submitted.

Manufacturer Narrative

Additional information received on the 28-oct-15 confirmed the bleed did not warrant intervention.As per fda guidelines/regulations (21 cfr 803.3) this event (bleeding) does not meet the definition of a serious injury as it was not life threatening (no intervention was warranted), it did not result in an impairment of a body function or body structure, it did not necessitate medical or surgical intervention.This event does not meet the criteria for a reportable 'serious injury'.A malfunction reporting precedence also does not exist for this complaint event.This event has be ae re-assessed and no longer meets the reporting criteria of an fda mdr report.

Event Description

This follow up report is being submitted to cancel the initial report submitted.The event information received indicated the outer catheter of the cystome (cst-10) device would not pass through the end of scope.The outer ring of the device did not move on the inner catheter to enlarge the initial puncture site.The user has indicated the bleed was caused as a result of trying to force the outer ring of the cst device down to dilate the puncture site up.The initial report was submitted based on the assumption the bleed was sufficient to meet the criteria of a 'serious injury' as per fda cfr regulations and was conservatively reported.Additional information received on the 28-oct-15 confirmed the bleed did not warrant intervention.As per fda guidelines/regulations (21 cfr 803.3) this event (bleeding) does not meet the definition of a serious injury as it was not life threatening (no intervention was warranted), it did not result in an impairment of a body function or body structure, it did not necessitate medical or surgical intervention.This event does not meet the criteria for a reportable 'serious injury'.A malfunction reporting precedence also does not exist for this complaint event.This event has be ae re-assessed and no longer meets the reporting criteria of an fda mdr report.

• 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: 5182883
• MDR Text Key: 29407237
• Report Number: 3001845648-2015-00212
• Device Sequence Number: 1
• Product Code: KNS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/15/2015
• Event Location: Hospital
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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