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

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

Patient Problems Urinary Tract Infection (2120); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2020

Event Type  Injury  

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 manufacturer date and expiration date are unknown.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f23013 captures the reportable event of medication required.

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, percutaneous access needle and 8/10 dilator sheath set were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced urinary tract infection (uti) and was given antibiotics.

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 upn and lot number; therefore, the manufacturer date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) and block h6 (patient code and impact code) have been updated to capture that this event will no longer be reportable.

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, percutaneous access needle and 8/10 dilator sheath set were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced urinary tract infection (uti) and was given antibiotics.***additional information received on (b)(6) 2023*** it was clarified by the physician that the patient did not experience urinary tract infection (uti).

• 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: 16350737
• MDR Text Key: 309260863
• Report Number: 3005099803-2023-00649
• 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: 02/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Race: Asian