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

Model Number	M0062101170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon was used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the balloon split inside the patient.Reportedly, the whole balloon was instantly removed from the patient.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon was used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon split inside the patient.Reportedly, the whole balloon was instantly removed from the patient.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Investigation results: a visual examination of the returned complaint device found that the balloon was unfolded and had been subjected to positive pressure.The device was retuned still attached to the boston scientific encore inflation unit.Functional evaluation was performed, and the balloon was inflated with possitive pressure applied; however, the balloon would not hold pressure due to a pinhole located at the center portion of the balloon material.This failure is likely due to factors encountered during the procedure, such as difficult patient anatomy; stenosis, calcification or tortuosity, that could have affected its performance and its intended purpose.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.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9150182
• Report Number: 3005099803-2019-04883
• Device Sequence Number: 3047037
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 03/24/2022
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0023533853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1