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

Catalog Number	FUS-120045-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(6).Patient code: ureteral lesion not labeled, prophylactic treatment with antibiotics ¿ not labeled device code: no known device problem 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 a male patient underwent a flexible ureteroscopy procedure because of nephrolithiasis left.After a retrograde pyelography the ureter was normal.There was no stent placed before though.After putting in the guide wire the doctor placed the flexor parallel ureteral access sheath 12 french without feeling any resistance and the sheath was not disconnected.The doctor went in with the flexible ureteroscope after taking out the guide wire and saw a normal proximal ureter.As reported, just on the distal edge of the sheath the doctor saw some fatty tissue.He moved back and saw a major lesion on the lateral ureter wall of a length of about 3cm.The doctor was shocked because he wasn't expecting this.It is not known if the patient underwent any procedures beforehand, like a ureteral stone removal or maybe radiation which could explain the damage of the ureter.After removing the uas, they placed a double ¿j¿ stent (dj) and prescribed high doses of antibiotics to prevent uro sepsis.No unintended portion of any of the devices was left in the patient¿s body.There were no additional procedures required due to the reported issues.There has been no adverse effect to the patient resulting from the reported event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the actual complaint device was not returned as it was disposed of by the user facility.Two unused flexor parallel ureteral access sheath and dilators were returned for analysis.In addition, a review of complaint history, the device history record, quality control data, and specifications was conducted.Two unopened packages labeled (b)(4) with label lot number 8625098 were received.Both packages were opened for investigation.Visual examination of both devices showed notch ports smooth and uniform, split from notch through the distal end appeared smooth with no visible flash or debris.The distal end hole was round and smooth.The transition between sheath and dilator was smooth to touch.Both devices were hydrated noting adequate lubricity.Slight curvature was noted on the taper on one dilator; curvature was likely caused by pressure on the package from shipment.There was no other physical damage observed on the devices.Based on the examination of the returned unused devices, they were both manufactured within specification.A review of the device history records for the complaint device lot number 8625098 found there were no non-conformances related to this complaint issue.A review of complaint history for lot number 8625098 revealed there have been no additional complaints associated with this complaint device lot.The device is provided with instructions for use on placement of the device.It was reported that there was no difficulty in the placement of the device.There were no anatomy issues reported that would likely contribute to the reported injury.The actual device was not returned; however, the two unused returned products met specification and no other complaints have been received against this lot.There is no evidence to suggest either the device itself, the placement of device or the patient¿s anatomy caused this complaint event.A definitive cause for this issue could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
There has been no new information received since the last medwatch report was submitted on 05jul2018.

• Brand Name: FLEXOR PARALLEL 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: 7664560
• Report Number: 1820334-2018-02028
• Device Sequence Number: 1918713
• Product Code: EZN
• UDI-Device Identifier: 00827002564367
• UDI-Public: (01)00827002564367(17)210226(10)8625098
• Combination Product (Y/N): N
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2021
• Device Catalogue Number: FUS-120045-P
• Device Lot Number: 8625098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WOLF COBRA, HIWIRE, UFI-626-RPC-LP, NEPHRODRAIN