MAUDE Adverse Event Report: COOK INC URETHRAL DILATION BALLOON CATHETER; KOE DILATOR, URETHRAL

Model Number	G17843
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
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
It was reported upon opening the packaging of the urethral dilation balloon catheter, the balloon was not equipped with the filiform tip.The filiform tip was not in the packaging.The urethra dilatation procedure to treat urethra strictures in a male patient was unable to proceed further because of the missing filiform tip.As reported there were no adverse consequences to the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual examination of the returned device was conducted.A review of complaint history, the device history record, drawings, manufacturing instructions, quality control data and specifications was also performed.One balloon catheter was returned for investigation.The customer stated the filiform tip was not in the packaging.A visual examination noted the returned device threads on the tip of the device appear to have been stripped.The balloon material appears to have been compromised.The device history record was reviewed and no non-conformances were found related to the reported issue.A review of complaint history no other complaint associated with the complaint device lot number ns7327488.A filiform is not included as one of the device components.The device has a tip that a filiform can be attached to.The device is supplied with the instructions for use (ifu) which includes a description of the device and provides a list of the included components.Set contains (set components may vary), urethral dilation balloon catheter,.038-inch (0.97 mm) diameter ptfe coated stainless steel wire guide 80 cm long with 3 cm flexible tip, syringe.A review of the ifu found there is one reference to a filiform in the ifu.This reference is found in the section titled: instructions for using urethral dilation balloon catheter.The reference states: note: when using filiform configuration, attach filiform using clockwise rotations prior to insertion.A filiform is not included as one of the components of the urethral dilation balloon catheter.The device has a tip that a filiform can be attached to.The cause for this complaint is the user was unaware that the device did not come with a filiform to attach to the tip of the device.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: URETHRAL DILATION BALLOON CATHETER
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7251838
• Report Number: 1820334-2018-00224
• Device Sequence Number: 1342824
• Product Code: KOE
• UDI-Device Identifier: 00827002178434
• UDI-Public: (01)00827002178434(17)191004(10)NS7327488
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K892855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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 Model Number: G17843
• Device Catalogue Number: UDBS-090029-FF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1