MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY UROMAX ULTRA?; DILATOR, CATHETER, URETERAL

Model Number M0062251210

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a uromax ultra kit was used during a transurethral ureterolithotripsy (tul) procedure performed on (b)(6) 2015.According to the complainant, after completion of balloon inflation during the procedure, the encore's gauge cover and needle detached.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Visual examination of the returned uromax balloon catheter revealed no cracks or damage on the hub.The catheter shaft had no kinks and the balloon had no tears or holes visible.The encore inflation device included in the kit was not returned for analysis.Functional analysis revealed that the balloon was inflated at 20atm using a different encore inflator and there were no leaks noted.Given the event description and condition of the returned device, the reported failure could not be confirmed.A review of the device history record (dhr) was performed; no anomalies were noted.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a uromax ultra kit was used during a transurethral ureterolithotripsy (tul) procedure performed on (b)(6) 2015.According to the complainant, after completion of balloon inflation during the procedure, the encore's gauge cover and needle detached.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: UROMAX ULTRA?
• Type of Device: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4663714
• MDR Text Key: 5686009
• Report Number: 3005099803-2015-00974
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• PMA/PMN Number: K980795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: M0062251210
• Device Catalogue Number: 225-121
• Device Lot Number: 16296229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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