MAUDE Adverse Event Report: COOK INC FLEXOR URETERAL ACCESS SHEATH AND DILATORS; EZN DILATOR, CATHETER, URETERAL

Catalog Number	FUS-120035
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
Event information received via sus voluntary event form received from hhs/fda.Reference: mw5074563.It was reported during use of the flexor ureteral access sheath and dilators, a piece of the sheath broke off inside the patient.The doctor was able to retrieve it.No adverse effect to the patient has been reported.The facility has been contacted to obtain additional patient and event information.At the time of this report there has been no new information received.
Additional Manufacturer Narrative
A review of complaint history, the device history record, and specifications was performed.A visual inspection and dimensional verification of the returned device was also conducted.One fus-120035 flexor sheath with label lot 8199569 was received.The dilator was not returned.The length of the sheath measured 35cm.The customer reported the sheath was broken off inside the patient.A specimen cup with a clear strip of material was received.No visible damage was observed on the outside diameter of the sheath.Under magnification light scrape marks were observed inside the white hub on the proximal end.The distal tip has a prominent scrape mark visible inside the tubing.The clear strip of material has been scraped from the inside of the sheath.The inside lining of the sheath has been scraped and sheared off by a sharp instrument of undetermined origin.There were no manufacturing anomalies observed with the dilator, lubricity of the components appeared to be sufficient.Review of the device history records for lot 8199569 did not reveal non-conformances related to this complaint issue.A review of complaint history for this product/lot number combination revealed there are no other complaints associated with this product lot number 8199569.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.The fus-120035 is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.The working channel protects the ureter during repeated instrument exchanges.The sheath also protects delicate instruments and smaller flexible scopes from damage.The sheath has a hydrophilic coating to create a low-friction surface as you dilate the ureter.No information was provided regarding other devices used in this procedure or if the other devices met their manufacturer¿s quality specifications.There is no mention of human anatomical difficulties involved with this event.There is no mention if the dilator/sheath were placed as a single unit as per the instructions for use (ifu).There is no information regarding preparation, handling or storage of the device.Based on the investigation and returned device evaluation, material evidence indicates the reported issue is the result of the interaction of devices used with the sheath, resulting in material being scraped from the interior lumen of the sheath and deposited in the patient.The root cause of the reported issue is related to user technique and the devices used within the sheath.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.- attachment: [pr217627_sus hhs_fda_mw5074563_recvd 05feb2018.Pdf_report source doc.Pdf] h3 other text : blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a review of complaint history, the device history record, and specifications was performed.A visual inspection and dimensional verification of the returned device was also conducted.One fus-120035 flexor sheath with label lot 8199569 was received.The dilator was not returned.The length of the sheath measured 35cm.The customer reported the sheath was broken off inside the patient.A specimen cup with a clear strip of material was received.No visible damage was observed on the outside diameter of the sheath.Under magnification light scrape marks were observed inside the white hub on the proximal end.The distal tip has a prominent scrape mark visible inside the tubing.The clear strip of material has been scraped from the inside of the sheath.The inside lining of the sheath has been scraped and sheared off by a sharp instrument of undetermined origin.There were no manufacturing anomalies observed with the dilator, lubricity of the components appeared to be sufficient.Review of the device history records for lot 8199569 did not reveal non-conformances related to this complaint issue.A review of complaint history for this product/lot number combination revealed there are no other complaints associated with this product lot number 8199569.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.The fus-120035 is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.The working channel protects the ureter during repeated instrument exchanges.The sheath also protects delicate instruments and smaller flexible scopes from damage.The sheath has a hydrophilic coating to create a low-friction surface as you dilate the ureter.No information was provided regarding other devices used in this procedure or if the other devices met their manufacturer¿s quality specifications.There is no mention of human anatomical difficulties involved with this event.There is no mention if the dilator/sheath were placed as a single unit as per the instructions for use (ifu).There is no information regarding preparation, handling or storage of the device.Based on the investigation and returned device evaluation, material evidence indicates the reported issue is the result of the interaction of devices used with the sheath, resulting in material being scraped from the interior lumen of the sheath and deposited in the patient.The root cause of the reported issue is related to user technique and the devices used within the sheath.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7286181
• Report Number: 1820334-2018-00455
• Device Sequence Number: 16642865
• Product Code: EZN
• UDI-Device Identifier: 00827002191686
• UDI-Public: (01)00827002191686(17)200907(10)8199569
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: FUS-120035
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention