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

Model Number	M0062101180
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 dilatation balloon catheter was used during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that the balloon had a pinhole.The procedure was completed with another nephromax dilatation balloon catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that the balloon had a pinhole.The procedure was completed with another nephromax dilatation balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Problem code 1504 captures the reportable event of balloon pinhole.A visual examination of the returned complaint device confirmed that the balloon was unfolded and had been subjected to positive pressure.A blood was also noted inside the balloon material which confirmed that the device had a leak.Functional evaluation was performed by attaching the device to encore inflation unit and positive pressure was applied when liquid was noted escaping from a pinhole leak in the balloon distal to the proximal balloon bond.No other issues were noted on the device.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.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 directions for use (dfu)/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: 8453027
• Report Number: 3005099803-2019-01439
• Device Sequence Number: 11169823
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/24/2019

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: 08/31/2020
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0021348424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1