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

Model Number	M0062101420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter device was used during a percutaneous nephrolithotomy (pcnl) procedure with shock pulse.During the procedure, upon inserting the nephromax balloon catheter, they noticed that the small gold radio opaque strip at the distal end of the working sheath fell off inside the patient.They attempted retrieval for approximately 30 minutes since it kept moving the dislodged tab into unreachable areas.Reportedly, another surgeon was able to visualize the gold tab and completely remove it from the patient.There were no patient complications or serious harm reported.
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of ro marker detached.Impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter device was used during a percutaneous nephrolithotomy (pcnl) procedure with shock pulse.During the procedure, upon inserting the nephromax balloon catheter, they noticed that the small gold radio opaque strip at the distal end of the working sheath fell off inside the patient.They attempted retrieval for approximately 30 minutes since it kept moving the dislodged tab into unreachable areas.Reportedly, another surgeon was able to visualize the gold tab and completely remove it from the patient using a two and three prong grasper from percutaneous set.The procedure was completed with another of the same device with no serious harm done to the patient.
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h2: additional information: block b5, block d7a, block e1 (initial reporter first name, initial reporter last name and initial reporter phone), block h6 (impact codes) and block h8.Block h6: device code a0501 captures the reportable event of ro marker detached.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter device was used during a percutaneous nephrolithotomy (pcnl) procedure with shock pulse.During the procedure, upon inserting the nephromax balloon catheter, they noticed that the small gold radio opaque strip at the distal end of the working sheath fell off inside the patient.They attempted retrieval for approximately 30 minutes since it kept moving the dislodged tab into unreachable areas.Reportedly, another surgeon was able to visualize the gold tab and completely remove it from the patient using a two and three prong grasper from percutaneous set.The procedure was completed with another of the same device with no serious harm done to the patient.
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of ro marker detached.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2301 captures the reportable event of additional device required.Block h11: investigation results the device was not returned for analysis; therefore, technical analysis could not be performed.Additionally, the reported event was not confirmed since it did not include a returned device or media review to identify any issue that confirms the reported allegation.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A risk review was completed and confirmed that the event of detachment of device or device component was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed and from the information available, this device was the device was used per the instructions for use (ifu) / product label.Based on the available information, the most probable cause of the reported problem cannot be established due to lack of evidence and without proper evaluation of the device, it remains unknown the most probable cause that contributed to the event.Therefore, an investigation conclusion code of cause not established was assigned to this investigation.Since the findings did not lead to a clear conclusion about the cause of the reported adverse event.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23671993
• Report Number: 2124215-2025-87503
• Device Sequence Number: 9984069
• Product Code: LJE
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0062101420
• Device Catalogue Number: M0062101420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/28/2025; 06/09/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/22/2025; 07/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown