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

Model Number	M0063905000
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: DAKOTA¿ NITINOL STONE RETRIEVAL DEVICE WITH OPENSURE¿ HANDLE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7628646
• Report Number: 3005099803-2018-02072
• Device Sequence Number: 13907861
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0063905000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention