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

Model Number M0062101180

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

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 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 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.

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
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9468984
• MDR Text Key: 170793322
• Report Number: 3005099803-2019-06094
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (y/n): N
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR