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

Model Number	M0062101600
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon kit was used in the kidney during a percutaneous nephrostomy procedure performed on (b)(6) 2017.According to the complainant, during the deflation, the balloon ruptured.There were no pieces of the balloon that detached inside the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Regarding the patient¿s condition at the conclusion of the procedure, it was noted that there were no adverse events or patient injury.

• Brand Name: NEPHROMAX¿ KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7070411
• Report Number: 3005099803-2017-03556
• Device Sequence Number: 1798257
• Product Code: LJE
• UDI-Device Identifier: 08714729834540
• UDI-Public: 08714729834540
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• 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): 11/16/2017

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: 07/31/2020
• Device Model Number: M0062101600
• Device Catalogue Number: 210-160
• Device Lot Number: 0021179629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1