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

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

Patient Problems Septic Shock (2068); Obstruction/Occlusion (2422)

Event Date 08/01/2020

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 a nephromax balloon, 8/10 dilator, percutaneous access needle and sheath imager ii set were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced ureteral obstruction and septic shock, requiring admission to intensive care unit (icu) and cystoscopy stent placement.

Manufacturer Narrative

Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e233605 and e2328 capture the reportable event of septic shock and ureteral obstruction.Imdrf impact codes f0801 and f2301 capture the reportable event of icu admission and cystoscopy stent placement.

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in august 2020.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: b5 (describe event or problem), and block h6 (patient codes) block h6: imdrf patient codes e233605 capture the reportable event of septic shock.Imdrf impact codes f0801 and f2301 capture the reportable event of icu admission and cystoscopy stent placement.

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 a nephromax balloon, 8/10 dilator, percutaneous access needle and sheath imager ii set were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced septic shock, requiring admission to intensive care unit (icu) and cystoscopy stent placement.

• 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: 16326885
• MDR Text Key: 309075635
• Report Number: 3005099803-2023-00603
• 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,Followup
• Report Date: 04/14/2023

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: 02/08/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White