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

Model Number	M0062101170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Initial reporter facility name: (b)(6) medical center.The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of two nephromax balloon kit used in the same patient and procedure.It was reported to boston scientific corporation that two nephromax balloon kits were used during a procedure performed on (b)(6) 2021.During the procedure, both balloons burst when inflated.There were no 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 e1: initial reporter facility name: (b)(6) medical center.Block h6: device 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 returned detached from the rest of the device.A full balloon circumferential tear was also noticed located at the proximal balloon bond.The detached section of the balloon was also found torn longitudinally, thereby confirming the reported event of balloon burst.Microscopic examination was performed and identified that the tip of the device was attached to the section of the balloon that was detached.A visual and tactile examination found that the inner shaft was stretched and was detached distal from the distal end of the hub.There was no markerbands present on the device.This failure is likely due to factors encountered during the procedure, such as difficult patient anatomy contributed to the longitudinal tear in the balloon material, with a balloon rupture an optimum balloon refold would have been compromised.With a compromised balloon refold the device would have encountered resistance at the sheath during removal from the patient.The balloon circumferential tear was most probably due to the user applying excessive tensile force when attempting to withdraw the device through the sheath during removal, resulting to the inner shaft being stretched, the markerband becoming loose, and detachment of the shaft and balloon section.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
Note: this report pertains to one of two nephromax balloon kit used in the same patient and procedure.It was reported to boston scientific corporation that two nephromax balloon kits were used during a procedure performed on (b)(6) 2021.During the procedure, both balloons burst when inflated.There were no 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
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11812004
• Report Number: 3005099803-2021-02196
• Device Sequence Number: 3161150
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 10/02/2022
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0024534250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1