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

Model Number	M0063303060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact event date is unknown; however it was reported that the procedure took place in sometime in (b)(6) 2017.Two additional physician names were given for this case: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplement mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was used for a rigid ureteroscopy procedure on an unknown date.According to the complainant, during the procedure, the pull wire of the gemini stone retrieval basket broke, and was unable to open.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 "normal".Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental mdr will be submitted.

• Brand Name: GEMINI¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6673724
• Report Number: 3005099803-2017-01990
• Device Sequence Number: 81580
• Product Code: FFL
• UDI-Device Identifier: 08714729074304
• UDI-Public: (01)08714729074304(17)20200331(10)20464394
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: M0063303060
• Device Catalogue Number: 330-306
• Device Lot Number: 20464394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1