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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used in the kidney during a percutaneous nephrolithotripsy (pnl) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon was torn and would not inflate.The procedure was completed with another nephromax nephrostomy balloon catheter device.There were no patient complications reported as a result of this event.Note: the photos submitted by the customer confirmed the torn on the distal section of the balloon material.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used in the kidney during a percutaneous nephrolithotripsy (pnl) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon was torn and would not inflate.The procedure was completed with another nephromax nephrostomy balloon catheter device.There were no patient complications reported as a result of this event.Note: the photos submitted by the customer confirmed the torn on the distal section of the balloon material.
Additional Manufacturer Narrative
Block h6: medical device code a0414 captures the reportable event of balloon torn.Block h10: investigation result a visual examination of the returned device found that the balloon was torn longitudinally from distal of the distal marker band extending across the proximal from the distal marker band, thereby confirming the reported event.A visual and tactile examinations revealed that there was no problem found to the tip and the shaft of the device.Additionally, no problem was observed on the markerbands.This failure is likely due to factors encountered during the procedure, such as difficult patient anatomy and interaction with the device and a stone when the device was being positioned, causing weakness in the balloon material, leading to the balloon bursting and longitudinal tear in the balloon material.Therefore, the most probable root cause is adverse event related to patient condition.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
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12915606
• Report Number: 3005099803-2021-06191
• Device Sequence Number: 20151451
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 02/10/2024
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0026784500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown