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

Model Number	G49219
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
The complainant reported that maximum pressure was applied (12 atm) and the balloon did not fully inflate.The balloon was removed from the patient and a small hole was found in the balloon.There were no reported adverse effects to the patient as a result of the reported product problem.

• 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: 7272568
• Report Number: 1820334-2018-00518
• Device Sequence Number: 14028696
• Product Code: FGE
• UDI-Device Identifier: 00827002492196
• UDI-Public: (01)00827002492196(17)170415(10)5805018
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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
• 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: G49219
• Device Catalogue Number: FS-BDB-4X4
• 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