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

Model Number	G14920
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional procedure was required.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 approximately two weeks after placing the rutner suprapubic balloon catheter, the physician found that the balloon had deflated.The device was removed and replaced, but there were no further injuries aside from this replacement procedure.

• 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: 7483839
• Report Number: 1820334-2018-01379
• Device Sequence Number: 13817156
• Product Code: KOB
• UDI-Device Identifier: 00827002149205
• UDI-Public: (01)00827002149205(17)161205(10)5935204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: G14920
• Device Catalogue Number: 081916
• 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: 05/03/2018
• 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