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

Model Number	M0062101600
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10808911
• Report Number: 3005099803-2020-05186
• Device Sequence Number: 3274588
• Product Code: LJE
• UDI-Device Identifier: 08714729834540
• UDI-Public: 08714729834540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: M0062101600
• Device Catalogue Number: 210-160
• Device Lot Number: 0025675799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1