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

Model Number M0062101620

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation results: visual analysis of the returned nephromax balloon material revealed that the balloon was torn/cut longitudinally.The tear was located in the mid-body of the balloon and measured 5mm in length.A microscopic examination of the balloon material identified no issues which could potentially have contributed to the tear.The complaint investigation indicates another device/drug/subsequent procedure caused the complaint event.The complaint does state that doctor may have accidently cut the balloon with a scalpel.Therefore, the most probable root cause classification for the reported failure is caused by other device.

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter kit was used during a percutaneous nephrolithotripsy (pnl) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the balloon would not inflate.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.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¿ 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: 6237626
• MDR Text Key: 64369989
• Report Number: 3005099803-2016-04132
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: M0062101620
• Device Catalogue Number: 210-162
• Device Lot Number: 19692487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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