MAUDE Adverse Event Report: COOK UROLOGICAL INC. ULTRAXX NEPHROSTOMY BALLOON & SET; LJE CATHETER, NEPHROSTOMY

Catalog Number UNBS-10-15

Device Problem Balloon rupture (1049)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2013

Event Type  malfunction  

Event Description

The balloon burst circumferentially by use at the patient.They made a pcnl with unbs.No section of the device remained in the patient or had to be retrieved.No additional procedures were required due to this occurrence.No adverse effects on the patient were reported to have occurred due to this event.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON & SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK UROLOGICAL INC.; spencer IN 47460
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3777331
• MDR Text Key: 18569751
• Report Number: 1820334-2014-00007
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/12/2013,12/11/2013

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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2016
• Device Catalogue Number: UNBS-10-15
• Device Lot Number: U2373392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2013
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR