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

Model Number	M0062101180
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr 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) 2019.According to the complainant, during the procedure, the balloon burst while pushing the oversheath over the balloon.Reportedly, the physician was instructed that the maximum atmospheric pressure of the nephromax balloon is 20 atm; however, the physician still inflated the balloon to 24 atm to remove the waist on it.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• 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: 8911235
• Report Number: 3005099803-2019-04073
• Device Sequence Number: 514626
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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 Model Number: M0062101180
• Device Catalogue Number: 210-118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1