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

Model Number	G49222
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: olympus endoscope, olympus introducer (104q), and a metii-35-480 wire guide.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.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Event or Problem Description
The complainant reported that the pressure gauge wouldn¿t go up during balloon inflation.The balloon was inserted into the cbd (common bile duct) and a leak was discovered when the balloon was removed; the hole was noted to be in the distal section of the balloon.The ercp (endoscopic retrograde cholangio-pancreatography) procedure was completed with a new balloon.There were no reported adverse consequences to the patient as a result of the 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: 7273422
• Report Number: 1820334-2018-00525
• Device Sequence Number: 18873060
• Product Code: FGE
• UDI-Device Identifier: 00827002492226
• UDI-Public: (01)00827002492226(17)180705(10)7093959
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• 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: G49222
• Device Catalogue Number: FS-BDB-10X4
• 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
• Patient Age: 82 YR
• Patient Weight: 60