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

Model Number	M0062101170
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy catheter balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, when the physician tried to inflate the balloon, the middle portion of the balloon would not fully inflate.It was also noticed that the catheter was kinked.The procedure was completed with another nephromax nephrostomy catheter balloon.The photos submitted by the customer confirmed the balloon irregular shape and catheter kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy catheter balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, when the physician tried to inflate the balloon, the middle portion of the balloon would not fully inflate.It was also noticed that the catheter was kinked.The procedure was completed with another nephromax nephrostomy catheter balloon.The photos submitted by the customer confirmed the balloon irregular shape and catheter kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406 captures the reportable event of balloon irregular shape.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406 captures the reportable event of balloon irregular shape.Block h10: investigation results: a visual examination of the returned complaint device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Solidified media was present in balloon.No damage was found on the balloon material, tip, and shaft of the device.Both markerbands were undamaged and present on the shaft of the device.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the device complaint or problem cannot be confirmed.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 instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy catheter balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, when the physician tried to inflate the balloon, the middle portion of the balloon would not fully inflate.It was also noticed that the catheter was kinked.The procedure was completed with another nephromax nephrostomy catheter balloon.The photos submitted by the customer confirmed the balloon irregular shape and catheter kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12432539
• Report Number: 3005099803-2021-04635
• Device Sequence Number: 14348935
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

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: 03/15/2024
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0026977464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 10/06/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/05/2021; 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR