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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DAKOTA; DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC CORPORATION DAKOTA; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 04/01/2018
Event Type  Injury  
Event Description
It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a dakota was used during a removal, calculus, ureter, ureteroscopic procedure performed on (b)(6) 2018.During procedure, patient experienced extraperitoneal bladder perforation.The patient was readmitted for a cystoscopy and transfusion with a foley catheter placement.
 
Manufacturer Narrative
Date of event: the exact date of the event is unknown.The provided event date was chosen as the best estimate based on the reported date of (b)(6) 2018.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
 
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Brand Name
DAKOTA
Type of Device
DISLODGER, STONE, BASKET, URETERAL, METAL
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 Key16263746
MDR Text Key308361604
Report Number3005099803-2023-00311
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/30/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2023
Initial Date FDA Received01/30/2023
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 Age59 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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