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.(b)(4).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.
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 results: 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.The device was returned attached to an encore inflation unit.Functional evaluation was performed and the balloon was successfully inflated to its rated burst pressure of 20 atm without problem; there were no leaks noted on the device, thereby the reported event of balloon bursting was not confirmed.A microscopic examination identified no problems with the balloon material, markerbands, shaft or tip of the device.The returned device showed no evidence of either the alleged problem or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint is no problem detected.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
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11812005
• Report Number: 3005099803-2021-02197
• Device Sequence Number: 3161151
• 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: 12/17/2023
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0026535214
• 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