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	Fever (1858); Perforation (2001)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated however; it was noticed that the balloon burst at 18 atm.Reportedly, the balloon was removed and a perforation was noted on the patients renal pelvis.The perforation was confirmed with a ct scan and no further action was taken to treat the perforation as it is believed to heal on its own; however, the hospital stay was extended to monitor the patient status.The procedure was completed with a retrograde stent.It was reported that after the procedure, the patient had a fever but it eventually subsided.The patient was then discharged after a few days.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated however; it was noticed that the balloon burst at 18 atm.Reportedly, the balloon was removed and a perforation was noted on the patients renal pelvis.The perforation was confirmed with a ct scan and no further action was taken to treat the perforation as it is believed to heal on its own; however, the hospital stay was extended to monitor the patient status.The procedure was completed with a retrograde stent.It was reported that after the procedure, the patient had a fever but it eventually subsided.The patient was then discharged after a few days.
Additional Manufacturer Narrative
Block h6: patient code e2114 captures the reportable event of perforation.Impact code f08 captures the reportable event of prolonged hospitalization.Device problem code a0402 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 indicates that the device was subjected to positive pressure.A microscopic examination was performed and it was noticed that the balloon was torn longitudinally from the distal markerband extending across the balloon material, thereby confirming the reported event of balloon burst.No problems were observed on the balloon material, markerbands, shaft and tip of the device.Based on the available information, there is no evidence of a manufacturing issue or design issue which could have caused the complaint and there is no evidence that the device failed to meet nephromax ng specification prior to shipping.Although the device was not inflated next to a stone, it is possible that the balloon had an interaction with a stone when the device was being positioned which caused weakness in the balloon material, resulting to balloon bursting and balloon torn when positive pressure was applied.Regarding the perforation of the renal pelvis with symptom of fever reported in the complaint, this is known potential adverse event related with the use of the device and are noted within the ifu.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.

• 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: 12459177
• Report Number: 3005099803-2021-04716
• Device Sequence Number: 4067391
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 10/26/2021

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 Expiration Date: 11/10/2022
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0026098548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization