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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX KIT; CATHETER, NEPHROSTOMY
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BOSTON SCIENTIFIC CORPORATION NEPHROMAX KIT; CATHETER, NEPHROSTOMY Back to Search Results
Model Number M0062101600
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 balloon dilatation catheter device was used in the kidney during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a pinhole was noted.Reportedly, the balloon was checked outside the patient and confirmed that the pinhole was in the middle part of the balloon.The procedure was completed with another nephromax balloon dilatation catheter.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: problem code 1504 captures the reportable event of balloon pinhole.Block h10: investigation result a visual examination of the returned device found that the balloon was not folded which indicated that the device was subjected to positive pressure.A microscopic examination of the balloon found a longitudinal tear beginning in the distal markerband and extending across the balloon material.The balloon material and the distal markerband identified no issues and the rated pressure for this device is 20 atm as per nephromax ng specification.A visual and tactile examination revealed no kinks or damage to the shaft.Based on the available information, it is possible that the factors encountered during the procedure and difficult patient anatomy could have caused the balloon to tear.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 instructions for use (ifu)/product label.
 
Event Description
It was reported to boston scientific corporation that a nephromax balloon dilatation catheter device was used in the kidney during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a pinhole was noted.Reportedly, the balloon was checked outside the patient and confirmed that the pinhole was in the middle part of the balloon.The procedure was completed with another nephromax balloon dilatation catheter.There were no patient complications reported as a result of this event.
 
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Brand Name
NEPHROMAX KIT
Type of Device
CATHETER, NEPHROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10808911
MDR Text Key215295758
Report Number3005099803-2020-05186
Device Sequence Number1
Product Code LJE
UDI-Device Identifier08714729834540
UDI-Public08714729834540
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,foreig
Type of Report Initial,Followup
Report Date 12/09/2020
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
Device Operator Health Professional
Device Expiration Date01/01/2023
Device Model NumberM0062101600
Device Catalogue Number210-160
Device Lot Number0025675799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Initial Date Manufacturer Received 10/16/2020
Initial Date FDA Received11/09/2020
Supplement Dates Manufacturer Received11/18/2020
Supplement Dates FDA Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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