MAUDE Adverse Event Report: COOK UROLOGICAL INC ASCEND AQ URETERAL BALLOON CATHETER; EZN DILATOR, CATHETER, URETERAL

Catalog Number AAUBS-5-10

Device Problem Balloon rupture (1049)

Patient Problem Tissue Damage (2104)

Event Date 03/14/2014

Event Type  Injury  

Event Description

A female patient underwent ureteroscopy with stent placement on (b)(6) 2014.The physician passed the balloon to dilate the proximal ureter.The balloon ruptured (the cook rep believes this might be due to over inflation).They could not get past the stricture.There was trauma to ureter.A stent was placed.It is unknown if the balloon rupture caused the trauma to the ureter or a need for intervention.The trauma could have been caused by overinflation.A stent is usually placed at end of this type of procedure.The patient may require an additional procedure to perform a lithotripsy procedure that twas originally intended to be performed during this procedure.

Manufacturer Narrative

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

• Brand Name: ASCEND AQ URETERAL BALLOON CATHETER
• Type of Device: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3760921
• MDR Text Key: 4420571
• Report Number: 1820334-2014-00165
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040127
• 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: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: AAUBS-5-10
• Device Lot Number: U2436478
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2013
• 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