MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY NEPHROMAX¿; CATHETER, NEPHROSTOMY

Model Number M0062101170

Device Problems Difficult To Position (1467); Malposition of Device (2616)

Patient Problem Perforation (2001)

Event Date 06/02/2017

Event Type  Injury  

Event Description

This report pertains to one of two complaint devices used in the same procedure.Manufacturer report 3005099803-2017-01812 addresses the nephromax dilatation balloon, while manufacturer report # 3005099803-2017-01814 addresses the amplatz renal sheath.It was reported to boston scientific corporation that a nephromax dilatation balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when they used a 20 cm amplatz renal sheath, it would not slide over the nephromax dilatation balloon.As they pushed to slide the sheath over the balloon, the balloon advanced and perforated the renal pelvis.It is unknown if there was additional intervention performed for the punctured renal pelvis.The procedure was not completed due to this event.Post procedure, there were no complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Investigation results: a visual examination and product analysis of the returned balloon catheter and the renal sheath of this device found no issues.The balloon inflated and deflated without resistance.It was noted that a 10mm mandrel passed freely through the sheath.The balloon was placed through the sheath, and was inflated to its rbp, the balloon was a perfect fit for the sheath.When the pressure was decreased slightly (as per dfu), the sheath freely moved over the balloon.It is clear from the condition of the returned balloon catheter and renal sheath that no issues existed which could potentially have contributed to the complaint and the problem occurred when the physician attempted to use the device with a longer sheath which was not supplied with the balloon catheter.Therefore, the most probable root cause of this complaint is caused by other device.A review of the device history record (dhr) was performed and confirmed that this device was manufactured in accordance with the device master record.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

Note: this report pertains to one of two complaint devices used in the same procedure.Manufacturer report 3005099803-2017-01812 addresses the nephromax dilatation balloon, while manufacturer report # 3005099803-2017-01814 addresses the amplatz renal sheath.It was reported to boston scientific corporation that a nephromax dilatation balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when they used a 20 cm amplatz renal sheath, it would not slide over the nephromax dilatation balloon.As they pushed to slide the sheath over the balloon, the balloon advanced and perforated the renal pelvis.It is unknown if there was additional intervention performed for the punctured renal pelvis.The procedure was not completed due to this event.Post procedure, there were no complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: NEPHROMAX¿
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6646223
• MDR Text Key: 77715557
• Report Number: 3005099803-2017-01812
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: (01)08714729012641(17)20191216(10)20087785
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2019
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 20087785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 08/04/2017
• Supplement Dates FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR