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

Model Number	M0062101620
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
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 balloon catheter was used in the kidney during a kidney stone removal percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the distal tip of the catheter kinked while inserting into the patient.The procedure was completed with another nephromax 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 good.
Additional Manufacturer Narrative
Block h6: problem code 2981 for the reportable issue of distal tip bent.Block h10: investigation results only the nephromax clear sheath was returned for analysis.A visual examination of the device found a damage at one end of the sheath.No other issues were noted on the device.This failure is likely due to factors or conditions related to procedure during the use of the device, such as the patient anatomy, position of the scope elevator, and/or the manner as the device was handled and manipulated, 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.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a kidney stone removal percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the distal tip of the catheter kinked while inserting into the patient.The procedure was completed with another nephromax 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 good.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 00 boston scientific way; marlborough MA 01752
• MDR Report Key: 9450418
• Report Number: 3005099803-2019-06000
• Device Sequence Number: 11299295
• Product Code: LJE
• UDI-Device Identifier: 08714729834526
• UDI-Public: 08714729834526
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 05/13/2022
• Device Model Number: M0062101620
• Device Catalogue Number: 210-162
• Device Lot Number: 0024243568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1