MAUDE Adverse Event Report: COOK INC S-CURVE URETHRAL DILATOR SET; KOE DILATOR, URETHRAL

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Perforation (2001); Swelling (2091)
Date of Event	04/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
During a urethral dilation procedure on the male patient, the junior registrar placed the guide wire and confirmed placement via "ii".He then placed the 12fr and the 14fr over the wire sequentially.The 16fr dilator was then used and it perforated the urethra, causing the scrotum to take on fluid and become enlarged.The consultant then took over, catheterized the patient for the swelling and treated the patient for the injuries caused.No adverse effect to the patient reported.Information was provided that this event is not 100% due to a faulty product as the doctor is very junior and user error could have come into play.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, specifications, trends and visual inspection of the device was conducted during the investigation.Photos: a review of the customer supplied photo(s) reveals the dilator has a jagged tear at the distal end.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have bee notified.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a urethral dilation procedure on the male patient, the junior registrar placed the guide wire and confirmed placement via "ii".He then placed the 12fr and the 14fr over the wire sequentially.The 16fr dilator was then used and it perforated the urethra, causing the scrotum to take on fluid and become enlarged.The consultant then took over, catheterized the patient for the swelling and treated the patient for the injuries caused.No adverse effect to the patient reported.Information was provided that this event is not 100% due to a faulty product as the doctor is very junior and user error could have come into play.No part of the device remained inside the patient.The patient's urethra was perforated and fluid entered the scrotum inflating it to about the size of an orange.The patient has since recovered from this.The patient was catheterized and the swelling went down and is now doing well.No adverse effect to the patient reported.

• Brand Name: S-CURVE URETHRAL DILATOR SET
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5646181
• Report Number: 1820334-2016-00290
• Device Sequence Number: 250359
• Product Code: KOE
• UDI-Device Identifier: 00827002327894
• UDI-Public: (01)00827002327894(17)181201(10)6418664
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K811833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2016

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 Model Number: N/A
• Device Catalogue Number: 073701-CD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2016
• Supplement Report FDA Received Date: 01/17/2017
• 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: Other