MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY

Model Number	M0062101420
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual examination of the returned complaint device found that the balloon was unfolded and had been subjected to positive pressure.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole leak located over the distal marekerband.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose such as; the manner as the device was handled, and/or the interaction with the scope during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician attempted to inflate the balloon; however, the balloon was unable to be inflated.Reportedly, the balloon was removed from the patient.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8920238
• Report Number: 3005099803-2019-04179
• Device Sequence Number: 2824127
• Product Code: LJE
• UDI-Device Identifier: 08714729826491
• UDI-Public: 08714729826491
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K121614
• 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): 08/22/2019

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: 10/12/2020
• Device Model Number: M0062101420
• Device Catalogue Number: 210-142
• Device Lot Number: 0021255455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1