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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) DAKOTA¿ NITINOL STONE RETRIEVAL DEVICE WITH OPENSURE¿ HANDLE DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) DAKOTA¿ NITINOL STONE RETRIEVAL DEVICE WITH OPENSURE¿ HANDLE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063905000
Device Problem Difficult to Open or Close (2921)
Patient Problem Internal Organ Perforation (1987)
Event Date 05/31/2018
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown. However, the complainant reported that the device was not expired. 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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a dakota¿ nitinol stone retrieval device with opensure¿ handle was used in the ureter and kidney during ureteroscopy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, when a stone was captured in the dakota¿ nitinol stone retrieval device with opensure¿ handle, the physician attempted to remove the stone through the access sheath. However, the stone was too large to be removed. An attempt to release the stone was done by trying to push the dakota¿ with entrapped stone back into the kidney, but again the stone was unable to be released. The end effector wire of the dakota¿ broke. The physician then pulled the dakota¿ with entrapped stone back to the access sheath, and removed them all together from the patient. During the removal, however, the ureter was perforated and was bleeding. A cautery device from another manufacturer was used to try to stop the bleeding, but is unknown if there was any treatment given for the perforation. 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 NameDAKOTA¿ NITINOL STONE RETRIEVAL DEVICE WITH OPENSURE¿ HANDLE
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7628646
MDR Text Key111976945
Report Number3005099803-2018-02072
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 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063905000
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 Received05/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/22/2018 Patient Sequence Number: 1
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