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 Hematuria (2558); Pseudoaneurysm (2605)

Event Date 05/01/2020

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a patient underwent percutaneous nephrolithotomy procedure in may 2020 using a percutaneous access needle.The patient experienced renal pseudoaneurysm, hematuria with clot retention and required cystoscopy clot evacuation and interventional radiology embolization.

Manufacturer Narrative

Date of event was approximated to may 1, 2020, as no exact date was reported.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e0513 and e1302 capture the reportable event of pseudoaneurysm and hematuria.Imdrf impact code f19 captures the reportable event of surgical interventions performed (cysto clot evacuation and ir embolization).

• 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: 16350763
• MDR Text Key: 309261341
• Report Number: 3005099803-2023-00491
• 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
• Report Date: 02/10/2023

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: 02/10/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White