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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematuria (2558)

Event Date 12/01/2018

Event Type  Injury  

Event Description

Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, nephromax balloon, introducer needles and 8/10 dilator sheath were used during a percutaneous nephrolithotomy (pcnl) procedure performed in december 2018.The patient experienced bladder clots.The patient required cysto clot evacuation under anesthesia and ureteral stent exchange.

Manufacturer Narrative

Date of event: the exact date is unknown; however, it was reported that the event occurred in december 2018.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacturer date and expiration date are unknown.Imdrf patient code (b)(6) capture the reportable event of hematuria.Imdrf impact codes f23, f19 and f2301 capture the reportable event of cysto clot evacuation under anesthesia and ureteral stent exchange (unexpected medical intervention, surgical intervention and additional device required.).

• Brand Name: NEPHROMAX
• Type of Device: 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: 16368127
• MDR Text Key: 309469365
• Report Number: 3005099803-2023-00523
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Race: White