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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 M0063301080
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a gemini basket was used during a cystoscopy, ureteroscopy with stone basket extraction procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the basket wire broke at the time the wire enclosed around the stone while the physician was attempting a stone extraction.The broken basket wire remained attached to the scope and was extracted directly through the scope.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
A visual analysis of the returned gemini basket was performed and it was found that the basket wire assembly was detached at the splice cannula, all basket wires were present and attached, all of the basket legs were noted to be straight, and the outer sheath was free of obvious defects.A functional evaluation was performed and it was noted that the pull wire assembly would operate smoothly without resistance.The sheath length was measured and it was within the specification.A review of the device history record (dhr) was performed and no issues were identified which might have caused or contributed to this complaint.  therefore, taking into consideration these factors and the analysis performed in the device returned, the most probable root cause will be ¿operational context.¿.
 
Event Description
It was reported to boston scientific corporation that a gemini basket was used during a cystoscopy, ureteroscopy with stone basket extraction procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the basket wire broke at the time the wire enclosed around the stone while the physician was attempting a stone extraction.The broken basket wire remained attached to the scope and was extracted directly through the scope.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
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Brand Name
GEMINI?
Type of Device
DISLODGER, 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
ingrid matte
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key3646595
MDR Text Key4183004
Report Number3005099803-2014-01226
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 Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/25/2016
Device Model NumberM0063301080
Device Catalogue Number330-108
Device Lot Number16488151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age48 YR
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