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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GEMINI¿ DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC - SPENCER GEMINI¿ DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063301070
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a gemini¿ basket was used in the ureter during a ureteroscopy procedure, performed on (b)(6) of 2017. According to the complainant, post procedure, the patient came back with a complaint of pain. The patient underwent surgery on (b)(6) 2018 and a yellow plastic sheath that was identified to be a part of a gemini¿ basket was found inside the ureter. The sheath of the basket was removed, and a stent was placed in the patient to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the surgery was reported to be fine.
 
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Brand NameGEMINI¿
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7278090
MDR Text Key100309221
Report Number3005099803-2018-00435
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/15/2020
Device Model NumberM0063301070
Device Catalogue Number330-107
Device Lot Number0021015429
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/16/2018 Patient Sequence Number: 1
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