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

Model Number M0062101180

Device Problem Difficult to Insert (1316)

Patient Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987)

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a nephromax kit was used during a percutaneous nephrolithotomy procedure.According to the complainant, during the procedure after the nephromax dilatation balloon was inflated the physician had a hard time inserting the sheath over the balloon and had to use lot of force to get it in.The physician was able to complete the procedure with this balloon, however, the physician stated that when he pushed the balloon in, there was some tearing in the kidney.Due to the tear in the kidney, fluid got into the patient and caused the patient to get sick.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that a nephromax kit was used during a percutaneous nephrolithotomy procedure.According to the complainant, during the procedure after the nephromax dilatation balloon was inflated the physician had a hard time inserting the sheath over the balloon and had to use lot of force to get it in.The physician was able to complete the procedure with this balloon, however the physician stated that when he pushed the balloon in, there was some tearing in the kidney.Due to the tear in the kidney,the patient experienced bleeding and contrast got into the patient and caused the patient to get sick.The procedure was completed with this device.The patient's conditions was reported to be fine post-procedure.

• Brand Name: NEPHROMAX?
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3652523
• MDR Text Key: 4201856
• Report Number: 3005099803-2014-01313
• Device Sequence Number: 1
• Product Code: LJE
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

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: Physician
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 02/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 68