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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INTRODUCER NEEDLES; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number M0067001210
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); Pseudoaneurysm (2605)
Event Date 03/01/2021
Event Type  Injury  
Event Description
This report pertains to one of three devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, nephromax balloon and percutaneous access needle were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced pseudoaneurysm and sepsis, requiring readmission, interventional radiology (ir) embolization and iv antibiotics.
 
Manufacturer Narrative
Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2021.The complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf patient code (b)(6) captures the reportable event of pseudoaneurysm.Imdrf patient code (b)(6) captures the reportable event of sepsis.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
 
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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 Key16362723
MDR Text Key309390988
Report Number3005099803-2023-00551
Device Sequence Number1
Product Code GBO
UDI-Device Identifier08714729077749
UDI-Public08714729077749
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K820867
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2023
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 NumberM0067001210
Device Catalogue Number700-121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/17/2023
Initial Date FDA Received02/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
Patient SexMale
Patient RaceWhite
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