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

Model Number M0062101170

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned nephromax balloon catheter revealed that the balloon catheter shaft identified no kinks or damage.An examination of the balloon material identified a longitudinal tear located over the distal markerband and it extended proximally along the balloon for a total length of 7.2cm.There were no issues identified on the balloon material and the markerband which could potentially have contributed to the tear.The actual sheath of the device was not returned for analysis.The most probable root cause classification of this investigation is operational context.This is defined as a complaint that is associated with a product that meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used during a left percutaneous nephrolithotomy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the balloon was placed in the patient under x-ray.The balloon ruptured at the distal tip while being inflated at 18 atm of pressure using an encore inflator.There were no balloon fragments left inside the patient 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 stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the balloon material had a longitudinal tear.

• 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: 5531177
• MDR Text Key: 41313908
• Report Number: 3005099803-2016-00768
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K952968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2018
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 18118788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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