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

Model Number M0062101170

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation results: visual examination of the returned nephromax balloon catheter revealed a 1 mm circumferential tear on the balloon body.Multiple kinks were also noted on the catheter shaft.The noted defects likely occurred due to anatomical/procedural factors encountered during the procedure that could have limited the performance of the balloon.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.There was no evidence to suggest that the device was used in a manner inconsistent with the labeled indications.

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a nephrostomy procedure preformed on (b)(6) 2017.According to the complainant, during the procedure, the balloon was leaking.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 stable.Investigation results revealed that the balloon had a circumferential tear; therefore, this is now an mdr reportable 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: 6776333
• MDR Text Key: 82114745
• Report Number: 3005099803-2017-02281
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: (01)08714729012641(17)20200209(10)0020268115
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2020
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0020268115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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