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

Model Number	M0062101180
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithotripsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was noted to be split.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.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithotripsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was noted to be split.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.
Additional Manufacturer Narrative
Block h6: problem code 4008 captures the reportable investigation result of balloon split.Block h10: investigation results: a visual examination of the returned complaint device found that the balloon was not folded which indicated that the device was subjected to positive pressure.A microscopic examination of the balloon found a balloon longitudinal tear located at the distal markerband and extending across the balloon material.No issues were noted on the balloon material, tip and the distal markerband.The rated burst pressure of the complaint device was 20 atmospheres as per nephromax ng specification.It was also noted that there were no kinks or damage to the shaft.This failure is likely due to factors or conditions related to the procedure during the use of the device, such as difficult patient anatomy that cold have caused the tear in the balloon material.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9457320
• Report Number: 3005099803-2019-06016
• Device Sequence Number: 3066372
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 03/13/2022
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0023925789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1