MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY NEPHROMAX¿ KIT; CATHETER, NEPHROSTOMY

Model Number M0062101640

Device Problem Material Rupture (1546)

Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888)

Event Date 11/16/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used in the kidney during a percutaneous nephrolithotomy procedure performed on (b)(6) 2015.According to the complainant, during the procedure and inside the patient, the nephromax dilatation balloon burst at 18atm.No part of the device fell inside the patient.Reportedly, the patient had significant bleeding and kidney embolism.The procedure was completed with another nephromax dilatation balloon catheter.The patient was placed under observation for a night.The bleeding eventually subsided after several days and the patient was reported to be fine.Additional attempts have been made to obtain follow up event details with no response from the clinician.

• Brand Name: NEPHROMAX¿ KIT
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5303061
• MDR Text Key: 33655508
• Report Number: 3005099803-2015-03680
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0062101640
• Device Catalogue Number: 210-164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization