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

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Date 06/16/2015

Event Type  Injury  

Event Description

According to the initial reporter, four incidents where it was impossible to implant/use the product regarding the percutaneous pigtail nephrostomy accessory set during a procedure on a single patient.The user had experienced difficulty advancing through the kidneys.At this time, it is unclear if any of these incidents may have led to repeated renal punctures, risks of kidney bruises, inability to implant during emergency situations and other unknown issues.Since the reporter has not indicated which of the four devices may have caused the adverse events, it was determined to report on this event as a side of caution.Additional information has been requested, however, it was not available at the time of this report.

Manufacturer Narrative

(b)(4).At this time it is unclear if any of these incidents may have led to repeated renal punctures, risk of kidney bruises, inability to implant during emergency.This event is currently under investigation.

Manufacturer Narrative

(b)(4).Investigation: a review of the complaint history, documentation, quality control (qc), specifications, functional testing and a visual inspection of the complaint device was conducted for the purpose of this investigation.Three dilators (6, 7, and 8fr) and a cook malecot catheter from a percutaneous pigtail nephrostomy accessory set was returned for investigation.The wire guide from the set was not returned for investigation.A visual examination of the devices noted the tips of the dilators appeared split and stretched.A cook medical.038¿ ptfe wire guide was passed successfully through each of the dilators and the malecot.The current controls in place for manufacturing qc are in place to assure functionality and device integrity prior to transportation.Each packaged device is sent with instructions for use.There is no evidence to suggest that the device was not made to specification.It is likely that the physician was unable to gain adequate access of the kidney with the guide wire, however, with the information provided a definitive root cause cannot be determined.

Event Description

According to the initial reporter, four incidents occurred where it was impossible to implant/use the product regarding the percutaneous pigtail nephrostomy accessory set during a procedure on a single patient.The user had experienced difficulty advancing through the kidneys.At this time, it is unclear if any of these incidents may have led to repeated renal punctures, risks of kidney bruises, inability to implant during emergency situations and other unknown issues.Since the reporter has not indicated which of the four devices may have caused the adverse events, it was determined to report on this event as a side of caution.Additional information has been requested, however it was not available at the time of this report.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4924208
• MDR Text Key: 17851234
• Report Number: 1820334-2015-00469
• Device Sequence Number: 1
• Product Code: KOB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K810368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2015,06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: N/A
• Device Catalogue Number: 080008
• Device Lot Number: U2383875
• Other Device ID Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2015
• Device Age: 22 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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): Other