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

Model Number	M0062101170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(6).(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 dilatation catheter balloon was used in a percutaneous nephrolithotomy (pcnl) with dilatation procedure performed in the kidney on an unknown date.According to the complainant, during the procedure, the balloon burst when attempted to be inflated.The procedure was completed with another nephromax dilatation catheter balloon.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 fine.
Additional Manufacturer Narrative
Initial reporter city: deakin, australian capital territory.(b)(4).Investigation result: a visual examination of the returned complaint device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Microscopic examination was performed and identified that the balloon had a longitudinal tear.There were no issues noted in the tip section of the device, the markerband and the shaft.This failure is likely due to factors encountered difficult patient anatomy such as stenosis, calcification or tortuosity which would have contributed to the complaint incident.That could have affected device 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.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation catheter balloon was used in a percutaneous nephrolithotomy (pcnl) with dilatation procedure performed in the kidney on an unknown date.According to the complainant, during the procedure, the balloon burst when attempted to be inflated.The procedure was completed with another nephromax dilatation catheter balloon.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 fine.Additional information received on (b)(6) 2019.It was reported to boston scientific corporation that a nephromax dilatation catheter balloon was used in a percutaneous nephrolithotomy (pcnl) with dilatation procedure performed in the kidney on (b)(6) 2019.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Problem code 1074 captures the reportable issue of balloon burst.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 dilatation catheter balloon was used in a percutaneous nephrolithotomy (pcnl) with dilatation procedure performed in the kidney on an unknown date.According to the complainant, during the procedure, the balloon burst when attempted to be inflated.The procedure was completed with another nephromax dilatation catheter balloon.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 fine.Additional information received on 11nov2019.It was reported to boston scientific corporation that a nephromax dilatation catheter balloon was used in a percutaneous nephrolithotomy (pcnl) with dilatation procedure performed in the kidney on (b)(6) 2019.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9281187
• Report Number: 3005099803-2019-05421
• Device Sequence Number: 2801471
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

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: 02/10/2020
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0020273121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/20/2019
• Supplement Date Received by Manufacturer: 11/10/2019; 11/26/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/26/2019; 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1