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 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned nephromax balloon dilatation catheter revealed there was a longitudinal tear in the balloon material.The tear was located at 1.5cm proximal to the proximal edge of the distal markerband and it extended proximally for a total length of 2cm.An examination of the balloon material identified no issues which could potentially have contributed to the tear.Therefore, the condition of the returned device confirms the reported.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, the balloon ruptured at 14 atm while it was inflated inside the patient.The procedure was completed with a different 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 stable.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: 5457117
• MDR Text Key: 38895457
• Report Number: 3005099803-2016-00374
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 18424791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2015
• 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