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

Model Number M0062101170

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation results: visual examination of the returned nephromax balloon dilatation catheter revealed that the device had been subjected to positive pressure and deflated and a pinhole leak was identified over the proximal markerband.No issues were noted with the markerbands that may contributed to the complaint incident.Based on all gathered information, the most probable root cause classification is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.(b)(4).

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used during a percutaneous nephrolithotomy procedure preformed on (b)(6) 2016.According to the complainant, during the procedure, the balloon failed to inflate.The procedure was completed with another nephromax balloon catheter.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 had pinhole.

• 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: 6078427
• MDR Text Key: 59132840
• Report Number: 3005099803-2016-03420
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2019
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 19176622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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