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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY
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BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY Back to Search Results
Model Number M0062101170
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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 Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on an unknown date.According to the complainant, during preparation, the balloon was noted to have thin holes when inflated prior to procedure.The procedure was completed with another nephromax dilatation balloon catheter kit.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Date of event: date of event was approximated to 09/01/2019 as no event date was reported.Problem code 1504 captures the reportable event of balloon pinhole.Investigation result: a visual examination of the complaint device revealed the balloon was subjected to positive pressure and re-folded.Functional analysis was performed, a longitudinal tear was noted from approximately 30mm distal of the proximal balloon bond and extending approximately 9mm distally.No issues were noted on the balloon material, markerband, tip and shaft.This failure is likely due to an interaction between the user and device, or sample, that caused or contributed to the error.It is likely that the failure may be related to the balloon being pre-tested and the handling of the device during 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 not used per the directions for use (dfu)/product label as the device was pre-inflated.
 
Event Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on an unknown date.According to the complainant, during preparation, the balloon was noted to have thin holes when inflated prior to procedure.The procedure was completed with another nephromax dilatation balloon catheter kit.There were no patient complications reported as a result of this event.
 
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Brand Name
NEPHROMAX
Type of Device
CATHETER, NEPHROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9172655
MDR Text Key177539200
Report Number3005099803-2019-04942
Device Sequence Number1
Product Code LJE
UDI-Device Identifier08714729012641
UDI-Public08714729012641
Combination Product (y/n)N
PMA/PMN Number
K121614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/02/2022
Device Model NumberM0062101170
Device Catalogue Number210-117
Device Lot Number0023587008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2019
Date Manufacturer Received10/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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