MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY

Model Number	M0062101170
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned complaint device revealed the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was noted to have a circumferential tear located at the proximal of the distal markerband.It was also noted that the balloon material is partially torn.A visual and tactile examination of the sheath identified that the sheath was split along its entire length.It is possible that some conditions related during the procedure, and/or related to the handling/manipulation applied to the device could have affected its performance and its intended purpose, leading to the observed failures and the reported adverse event.However, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labelling review was performed, and there was no evidence to suggest that the device was used in a manner inconsistent with the labelled indications.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used in the right kidney during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the access sheath broke when it was inserted over the inflated balloon.The procedure was completed with another nephromax balloon catheter.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8815809
• Report Number: 3005099803-2019-03588
• Device Sequence Number: 16731428
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K121614
• 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
• Report Date (Section B): 07/23/2019

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: 08/06/2021
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0022475888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR