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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.(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 dilatation catheter device was used in the right kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the same balloon was used to proceed to a second access dilatation and while inflating the balloon burst.The procedure was completed with another nephromax balloon dilatation catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon dilatation catheter device was used in the right kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the same balloon was used to proceed to a second access dilatation and while inflating the balloon burst.The procedure was completed with another nephromax balloon dilatation catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Additional information received on december 11, 2019.Reportedly, the balloon burst at 16 atm.
Additional Manufacturer Narrative
Correction: (initial reporter phone).Additional information: description of event or problem.The complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.Problem code 1074 captures the reportable event of balloon burst.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.

• 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: 9468984
• Report Number: 3005099803-2019-06094
• Device Sequence Number: 4130535
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR