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

Model Number	M0062101400
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the complaint device revealed that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was also identified within the balloon which is an evidence of a device leak and would suggest that the device had been used.Functional analysis was performed, and the balloon was inflated; however, a pinhole was found on the distal of the proximal balloon bond.The balloon material, tip and markerband had no issues.A visual and tactile examination identified no kinks or damage to the shaft.It is likely that the failure may be related to the contact with a sharp object during preparation for the procedure.Therefore, the most probable root cause is unintended use error caused or contributed to event.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 nephrostomy balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during preparation, it was noticed that the balloon leaked from the tip.The procedure was completed with another nephromax nephrostomy balloon catheter.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.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: 10319636
• Report Number: 3005099803-2020-02894
• Device Sequence Number: 14247580
• Product Code: LJE
• UDI-Device Identifier: 08714729826484
• UDI-Public: 08714729826484
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 07/24/2020

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: 04/07/2022
• Device Model Number: M0062101400
• Device Catalogue Number: 210-140
• Device Lot Number: 0023607382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1