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

Model Number M0062101170

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the balloon burst when inflated at 8 atm.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Investigation results: visual examination of the returned nephromax balloon catheter revealed that the balloon material had a longitudinal tear starting at the distal markerband and extending proximally along the balloon for a total length of 85 mm.There were no issues identified on the balloon material and the markerband which could potentially have contributed to the tear.It was also noted that the shaft was kinked at 345 mm distal to the strain relief.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 percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the balloon burst when inflated at 8 atm.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.

• 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: 6181521
• MDR Text Key: 62689045
• Report Number: 3005099803-2016-03954
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

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: 08/28/2019
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0019649374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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