MAUDE Adverse Event Report: COOK INC RUTNER SUPRAPUBIC BALLOON CATHETER SET; KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Model Number	G15261
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 the rutner suprapubic balloon catheter was placed percutaneously in the urinary bladder for a cystostomy.Approximately 7 days later, it was noticed that urine was not draining.Echographic examination confirmed that the catheter migrated, and the tip of the catheter was not placed inside the urinary bladder.The balloon was noted to be damaged when the physician removed the device.Another rutner suprapubic balloon catheter (unknown lot number) was placed instead.Aside from the additional procedure that was required to replace the device, there was no additional patient harm reported for this event.

• Brand Name: RUTNER SUPRAPUBIC BALLOON CATHETER SET
• Common Device Name: KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7479556
• Report Number: 1820334-2018-01349
• Device Sequence Number: 11091464
• Product Code: KOB
• UDI-Device Identifier: 00827002152618
• UDI-Public: (01)00827002152618(17)170110(10)6023949
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G15261
• Device Catalogue Number: 081912
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/02/2018
• 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