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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 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).
 
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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 Key16350763
MDR Text Key309261341
Report Number3005099803-2023-00491
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 02/10/2023
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 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 Received02/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexMale
Patient RaceWhite
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