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

Model Number M0062101180

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned nephromax balloon dilatation catheter revealed that a longitudinal tear existed in the balloon material.The tear was located over the distal markerband and it extended proximally along the balloon for a total length of 5cm.No issues were noted with the material of the balloon which could potentially have contributed to the tear.Based on all gathered information, the most probable root cause classification is operational context.

Event Description

It was reported to boston scientific corporation that a nephromax balloon dilatation catheter was used during a percutaneous nephrolithotomy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, balloon ruptured inside the patient.The procedure was completed with another nephromax balloon dilatation 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.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.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the balloon was torn longitudinally.

• 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: 5446840
• MDR Text Key: 38633866
• Report Number: 3005099803-2016-00373
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• 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: 01/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 18367699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2015
• 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