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 Problem Pleural Effusion (2010)

Event Date 03/01/2021

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 percutaneous access needle, nephromax balloon, 8/10 dilator, and sheath imager ii set were used during a left percutaneous nephrolithotomy procedure performed in march 2021.The patient experienced pleural effusion due to malposition stent and required cystoscopy stent exchange.

Manufacturer Narrative

Date of event: the exact date is unknown; however, it was reported that the event occurred in march 2021.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.(b)(6).

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2021.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: block b5 (describe event or problem) has been updated based on the additional information received on february 8, 2023.Block h6: imdrf patient code e0731 captures the reportable event of pleural effusion.Imdrf impact code f2301 capture the reportable event of cystoscopy stent exchange.Additional information received on 08feb2023 confirmed that this event was reported to boston scientific in error and is not considered a complaint.Report number 3005099803-2023-00521 was reported in error.Therefore, this event no longer represents an mdr-reportable scenario, and will be closed as not a complaint.

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 percutaneous access needle, nephromax balloon, 8/10 dilator, and sheath imager ii set were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced pleural effusion due to malposition stent and required cystoscopy stent exchange.It was clarified that the event is not related to the percutaneous access needle, nephromax balloon, 8/10 dilator sheath set, and imager ii.

• 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: 16329364
• MDR Text Key: 309124023
• Report Number: 3005099803-2023-00521
• 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: 02/16/2023

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: 02/08/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/16/2023
• 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: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White