MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number	ULT12.0-38-25-P-5S-CLDM-HC
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/20/2015
Type of Reportable Event	Serious Injury
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
It was reported that a patient of unknown age and gender had a biliary stent in place and underwent a procedure to have a biliary drain placed above the biliary stent as a backup.Two hours after the procedure while in recovery it was noted to be leaking at the hub.The patient was taken back to have the drain replaced.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any additional adverse effects due to this occurrence.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7018361
• Report Number: 1820334-2017-03996
• Device Sequence Number: 1014086
• Product Code: GBO
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)180828(10)6163811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/10/2017
• 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: Required Intervention