MAUDE Adverse Event Report: COOK UROLOGICAL INC PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET; KOB CATHETER, SUPRAPUBIC ( AND ACCESSORIES)

Catalog Number 080010

Device Problem Break (1069)

Patient Problem Foreign body, removal of (2365)

Event Date 06/26/2014

Event Type  Injury  

Event Description

Dilator broke in half while dilating.Half of the dilator was left in the patient.The device was removed from the patient successfully with no harm or need to additional procedures.

Manufacturer Narrative

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

• Brand Name: PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET
• Type of Device: KOB CATHETER, SUPRAPUBIC ( AND ACCESSORIES)
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3980948
• MDR Text Key: 4816375
• Report Number: 1820334-2014-00313
• Device Sequence Number: 1
• Product Code: KOB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 080010
• Device Lot Number: U2413160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• 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 Outcome(s): Required Intervention