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

Model Number	M0062101180
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2020
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 dilatation balloon catheter device was used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was noted to be fatigued and ruptured at 16atm.The procedure was completed with another nephromax balloon dilatation catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code 1074 captures the reportable event of balloon burst.Block h10: investigation result.A visual examination of the returned complaint device found that the balloon was not folded which indicated that the device was subjected to positive pressure.A microscopic examination was performed and a partial balloon circumferential tear was noticed located in the distalal section of the proximal sleeve.No other issues were noted in the balloon material, markerbands,and tip of the device.A visual and tactile examination identified no kinks or damage to the shaft.This failure is likely due to factors or conditions related to the procedure during the use of the device, such as difficult patient anatomy such as kidney stones that could have caused the balloon to rupture.With the compromised balloon refold the device would have encountered resistance at the sheath on removal from the patient.The balloon partial circumferential tear was most probably due to the user applying excessive tensile force when attempting to withdraw the device through the sheath on removal.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 dilatation balloon catheter device was used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was noted to be fatigued and ruptured at 16atm.The procedure was completed with another nephromax balloon dilatation catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• 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: 10626448
• Report Number: 3005099803-2020-04353
• Device Sequence Number: 3559582
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 03/13/2022
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0023955622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR