MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTRODUCER NEEDLES; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number M0067001210

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  

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 percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced urinary tract infection and required antibiotics.

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 lot number; therefore, the manufacturer date and expiration date are unknown.Imdrf patient codes e1310 capture the reportable event of urinary tract infection.Imdrf impact codes f23013 capture the reportable event of medication required.

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacturer date and expiration date are unknown.Block h2: additional information: block b1 (adverse event/product problem), b5 (describe event or problem) and 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 percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced urinary tract infection and required antibiotics.Additional information received on march 20, 2023: it was clarified by the physician that the patient did not experience urinary tract infection (uti).

• Brand Name: INTRODUCER NEEDLES
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16335650
• MDR Text Key: 309157446
• Report Number: 3005099803-2023-00648
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729077749
• UDI-Public: 08714729077749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820867
• 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: 04/17/2023

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
• Device Model Number: M0067001210
• Device Catalogue Number: 700-121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 04/17/2023
• 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