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

Model Number M0062101640

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 01/09/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when the anatomy was accessed from above the 11th rib, the sheath buckled and its tip became blunt, which sheared the tissue and caused more bleeding.No further intervention was required to control the bleeding and the procedure was completed with this device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• 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: 6281137
• MDR Text Key: 65869452
• Report Number: 3005099803-2017-00140
• 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: 01/09/2017

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: 01/09/2017
• Initial Date FDA Received: 01/26/2017
• 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