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

Model Number	M0062101180
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used on a percutaneous nephrolithotomy (pcnl) procedure performed on an unknown date.According to the complainant, during the procedure, the balloon burst.There was no piece of the balloon detached inside the patient.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Visual examination of the returned nephromax balloon catheter revealed that balloon was subjected to positive pressure and deflated.The balloon material was noted to have a circumferential tear beginning 24mm distal to the balloon bond and a longitudinal tear for 113mm distally across the balloon beginning at circumferential tear site.There were no issues identified on the markerband and shaft of the device which could potentially have contributed to the complaint incident.This is defined as a complaint that is associated with a product that meets the design and manufacturing specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.The most probable root cause classification of this investigation 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.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used on a percutaneous nephrolithotomy (pcnl) procedure performed on an unknown date.According to the complainant, during the procedure, the balloon burst.There was no piece of the balloon detached inside the patient.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: NEPHROMAX¿
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6568567
• Report Number: 3005099803-2017-01509
• Device Sequence Number: 13736734
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: (01)08714729077589(17)20171031(10)17698081
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K952968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 17698081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1