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

Model Number	M0063301090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was under the age of 18.(b)(4).A visual evaluation of the returned device found that the basket was returned separated from the device.The sheath was severely kinked and slightly torn at the distal end.The basket wire assembly was broken from the pull wire joint, and presented evidence of bending.The kinked area found on the sheath coincided with the broken section in the pull wire joint.The evaluation concluded that during the procedure, excessive manipulation of the device by the user, and interaction with other devices most likely contributed to the failures found and affected the integrity of the device.Handling and manipulation of the device during procedure can lead to kinking of the device, and severe kinking of the sheath can cause the sheath to tear and cause breakage to the pull wire joint to basket wire assembly.Therefore, the most probable root cause of this complaint is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a gemini¿ urology stone retrieval basket was used in the ureter during a ureteroscopy with stone retrieval procedure, performed on (b)(6) 2017.According to the complainant, during the procedure, the sheath became loose at the handle.During extraction of a stone, the basket¿s sheath detached at the handle connection.The procedure was completed with another gemini¿ urology stone retrieval basket.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 "stable".This event has been deemed a reportable event based on the investigation results; pull wire -broken.

• 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: 7239132
• Report Number: 3005099803-2018-00156
• Device Sequence Number: 16401985
• Product Code: FFL
• UDI-Device Identifier: 08714729043355
• UDI-Public: 08714729043355
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/15/2018

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: 10/03/2020
• Device Model Number: M0063301090
• Device Catalogue Number: 330-109
• Device Lot Number: 21214468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1