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

Model Number	M0062101440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon was used in the right kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the inflation, the balloon burst.There were no pieces of the balloon that detached inside the patient.The procedure was completed with another nephromax dilatation balloon.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 stable.

• Brand Name: NEPHROMAX¿
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6812783
• Report Number: 3005099803-2017-02514
• Device Sequence Number: 19082460
• Product Code: LJE
• UDI-Device Identifier: 08714729826507
• UDI-Public: (01)08714729826507(17)20190817(10)19608550
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2019
• Device Model Number: M0062101440
• Device Catalogue Number: 210-144
• Device Lot Number: 19608550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1