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

Model Number	M0062101180
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/11/2021
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 catheter kit was used during a procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon split open upon second inflation which increased the bleeding on the patient.Reportedly, the bleeding was controlled and there were no further patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h2: additional information: block h10 (additional mfr narrative) block d4, h4: the reported lot number (25981904) is for the whole nephromax kit.However, the lot number of the individual balloon inside the kit is 24589860.Block h6: device code a0414 captures the reportable event of balloon torn.Block h10: investigation result the returned nephromax balloon catheter kit was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also observed that the balloon was torn longitudinally from the distal of the distal markerband extending proximally across the balloon material, thereby confirming the reported event.No problems were identified to the balloon material and markerbands.A visual and tactile analysis were performed to the catheter shaft and the tip, and no kinks or damaged were found.No other problems with the device were noted.The reported event was confirmed.It is possible that the difficult patient anatomy, lesion characteristics, and the interaction between the balloon and the stones could have caused the rupture in the balloon material.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the 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 catheter kit was used during a procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon split open upon second inflation which increased the bleeding on the patient.Reportedly, the bleeding was controlled and there were no further patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11580933
• Report Number: 3005099803-2021-01344
• Device Sequence Number: 17189175
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 10/07/2022
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0025981904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown