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

Model Number M0062101620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/02/2015

Event Type  Injury  

Event Description

Note: this report pertains to one of three complaint devices used in the same procedure.Manufacturer report # 3005099803-2015-02127 addresses the 8/10 renal dilator, and manufacturer report # 3005099803-2015-01980 addresses the sensor wire guidewire it was reported to boston scientific corporation that a sensor wire guidewire, 8/10 renal dilator and a nephromax dilatation balloon was used during a percutaneous nephrolithotomy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, a sensor wire guidewire was inserted into the patient's kidney followed by a 8/10 renal dilator.A nephromax dilatation balloon was also inserted and after balloon dilatation, the physician noticed a puncture in the phylum near the uteropelvic junction.It was unknown which of the three devices could have caused the puncture.Reportedly, there was no alleged malfunction noted to the devices.There was no intervention done to treat the injury.The procedure was completed with this sensor wire guidewire, 8/10 renal dilator and a nephromax dilatation balloon.Post procedure, the patient was under observation and there were no complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: NEPHROMAX? KIT
• Type of Device: CATHETER, NEPHROSTOMY
• 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: 4946876
• MDR Text Key: 6640131
• Report Number: 3005099803-2015-02085
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: M0062101620
• Device Catalogue Number: 210-162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/28/2015
• 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): Other