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	08/08/2019
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 dilatation balloon catheter was used in a percutaneous nephrolithotomy (pnl) procedure was performed in the right kidney on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon burst when inflated below the limit pressure.The procedure was completed with another nephromax dilatation 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 good.
Additional Manufacturer Narrative
Block h6: problem code 1074 captures the reportable issue of balloon burst.Block h10: investigation results a visual examination of the returned complaint device found that the balloon was not folded which indicates that the device was subjected to positive pressure.Functional evaluation was performed by attaching the device into an encore inflation unit, the balloon was inflated to its rate of burst pressure of 20 atm without problem.A vacuum was then applied.The inflation device was verified at 20 atm before and after use with a calibrated pressure gauge.The device was inflated to 20 atm three times repeteadly with no leaks or drop in pressure noted; no issues were identified with balloon inflation or the balloon material.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint is no problem detected.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 balloon catheter was used in a percutaneous nephrolithotomy (pnl) procedure was performed in the right kidney on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon burst when inflated below the limit pressure.The procedure was completed with another nephromax dilatation 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 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: 8946109
• Report Number: 3005099803-2019-04321
• Device Sequence Number: 11415489
• 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,Followup
• Report Date (Section B): 09/19/2019

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: 11/15/2021
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0022952371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR