MAUDE Adverse Event Report: COOK INC FUSION TITAN DILATION BALLOON; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G49221
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography procedure, the fusion titan dilation balloon was inserted to dilate the biliary stricture.During first inflation a leak formed, a hole was noted in the balloon.The procedure was completed with another device.A section of the device did not remain inside the patient¿s body.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.

• Brand Name: FUSION TITAN DILATION BALLOON
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7273826
• Report Number: 1820334-2018-00517
• Device Sequence Number: 10793779
• Product Code: FGE
• UDI-Device Identifier: 00827002492219
• UDI-Public: (01)00827002492219(17)180228(10)6774795
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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: G49221
• Device Catalogue Number: FS-BDB-8X4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1