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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was being used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon popped at 20 atm when inflated inside the patient.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
Block h2: additional information: block b5 (describe event or problem), block d7 (sud reprocessed and reused) and block h8 (usage of device) block h6: device code a0402 captures the reportable event of balloon burst.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was being used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon popped at 20 atm when inflated inside the patient.The procedure was completed with another nephromax dilatation balloon catheter.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2021*** the device was used in the kidney.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12544524
• Report Number: 3005099803-2021-05104
• Device Sequence Number: 17163831
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 03/28/2024
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0027052364
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1