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

Model Number	M0062101400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure preformed on (b)(6) 2017.According to the complainant, during the procedure, the balloon burst when it was inflated at 14 or 15 atm.No pieces were detached from the balloon.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 as "no patient consequences".
Additional Manufacturer Narrative
Investigation results visual examination of the returned nephromax balloon catheter revealed a longitudinal tear on the balloon body.A kink was 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 or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure preformed on (b)(6) 2017.According to the complainant, during the procedure, the balloon burst when it was inflated at 14 or 15 atm.No pieces were detached from the balloon.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 as "no patient consequences".

• Brand Name: NEPHROMAX¿
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6623290
• Report Number: 3005099803-2017-01790
• Device Sequence Number: 16360430
• Product Code: LJE
• UDI-Device Identifier: 08714729834540
• UDI-Public: (01)08714729834540(17)20191231(10)20354789
• Combination Product (Y/N): N
• 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): 06/01/2017

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: 01/18/2020
• Device Model Number: M0062101400
• Device Catalogue Number: 210-140
• Device Lot Number: 20176706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1