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

Catalog Number	FUS-120045
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: non-healthcare professional.(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
It was reported, the user opened the package of the flexor ureteral access sheath and dilators and used water to active the hydrophilic coating, but found out the there was white emulsions like matter coming off from the sheath.The user tested the sheath with their hand and felt resistance on the surface of the sheath.The user suspected the hydrophilic coating is absent from the sheath.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Additional information received 05dec2018.The procedure was completed with another same product.Latex gloves were worn and the coating was activated with saline.
Additional Manufacturer Narrative
Investigation/evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, and specifications.The customer returned one opened package labeled part number fus-120055 with label lot number 8981845.Device was received assembled together.The dilator was removed from the sheath and hydrated, proper lubricity was confirmed.The sheath was hydrated confirming lubricity started 21cm from the distal tip and extending 11cm down the sheath.Photo sent by the customer displays a cloudy substance on the distal tip of the dilator tip and sheath.The origin of the cloudy substance is unknown.Inconsistent coating on the sheath was confirmed.A review of the device history record found there were no non-conformances related to the reported failure.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 8981845.As per the instructions for use (ifu): flexor ureteral access sheath: aq hydrophilic coating is applied to the dilator/sheath assembly to ease placement.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Examination of the returned device revealed the hydrophilic coating was not present over the entire surface of the sheath.It is possible the coating was removed during handling or activation of the hydrophilic coating, but a definitive cause for the missing coating and white emulsion could not be determined.Measures have been initiated to address this failure mode.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: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8065211
• Report Number: 1820334-2018-03379
• Device Sequence Number: 11378557
• Product Code: KOE
• UDI-Device Identifier: 00827002461680
• UDI-Public: (01)00827002461680(17)210627(10)8981845
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2021
• Device Catalogue Number: FUS-120045
• Device Lot Number: 8981845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1