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

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

Patient Problem Urinary Tract Infection (2120)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2023 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithotomy procedure performed on an unknown date.According to the literature, the patient underwent trans-scrotal percutaneous cystolitholapaxy through his existing foley catheter insertion site.He was taken to the operating room and placed in dorsal lithotomy position.His existing foley catheter was removed and a 0.035 sensor wire was passed through the existing tract into the bladder.A nephromax balloon was passed over a working wire and inflated to 16 atm for 5 min.Next, a 15 cm x 30 fr nephromax sheath was advanced over the balloon into the bladder followed by a rigid nephroscope immediately revealing the largest stone in the scrotal portion of the bladder.The stone was fragmented and removed with the aid of grasper devices and ultrasonic lithotripsy.Flexible cystoscopy then revealed a 1 cm stone in the pelvic portion of the bladder, which was removed intact with a basket.No other stones were visualized in the bladder.Fluoroscopy revealed no additional bladder stones; however, there was residual stone burden at the level of the prostatic urethra.Cystoscopic evaluation through the urethra revealed complete obliteration of the lumen at the level of the bulbar urethra.The access sheath was removed and a 20fr council-tip catheter was passed over the safety wire into the bladder.At this point the procedure was terminated, and the patient successfully extubated.The patient was discharged following the procedure.He was without further urinary tract infections and continued with monthly catheter exchanges for management of his lower urinary tract obstruction.He was last seen by urology three months post-operatively for inpatient catheter exchange during an admission for aspiration pneumonia, which unfortunately proved to be fatal.No further information has been obtained good faith efforts.

• 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: 17183283
• MDR Text Key: 317725325
• Report Number: 3005099803-2023-03225
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2023

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: 05/26/2023
• Initial Date FDA Received: 06/22/2023
• 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: 90 YR
• Patient Sex: Male