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

Model Number M0062101600

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

Visual analysis of the returned nephromax balloon catheter revealed that the catheter shaft no kinks or damage.A longitudinal tear was identified in the balloon.The tear from the distal markerband extended proximally along the balloon material for a total length of 14mm.A microscopic examination of the balloon material identified no issues which could potentially have contributed to the pinhole leak.Therefore, the complaint was confirmed.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter kit was used during a renal lithotripsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the balloon was inflated at 18atm and contrast was leaking at the distal portion of the balloon as seen in the ct monitor.Reportedly, the balloon did not rupture and the procedure was completed with another nephromax balloon catheter.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 good.

• Brand Name: NEPHROMAX¿ KIT
• 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: 5678253
• MDR Text Key: 45864947
• Report Number: 3005099803-2016-01445
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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
• Report Date: 05/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: M0062101600
• Device Catalogue Number: 210-160
• Device Lot Number: 18536099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2015
• 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