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

Model Number	M0063301060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gemini¿ urology stone retrieval basket was used during an ureterolithotripsy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the basket broke inside the patient.The broken piece was removed using forceps.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.
Additional Manufacturer Narrative
A visual analysis of the returned device revealed that the sheath was found to be bent at the distal end.Additionally, it was found that the pull wire, at its distal section, was broken when the sheath was removed upon further evaluation.Functional evaluation revealed that the device would not open.The evaluation concluded that the returned unit was consistent with the complaint incident that the basket cage was detached.During the procedure manipulation of the device and interaction with the scope or other devices most likely contributed to the failure pullwire broken and sheath bent.Therefore, the most probable root cause of this complaint is ¿operational context¿, since 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 revealed that no similar complaints exist for the specified lot.A labeling review was performed and no anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that a gemini¿ urology stone retrieval basket was used during an ureterolithotripsy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the basket broke inside the patient.The broken piece was removed using forceps.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.

• 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: 6443015
• Report Number: 3005099803-2017-00877
• Device Sequence Number: 1200225
• Product Code: FFL
• UDI-Device Identifier: 08714729087403
• UDI-Public: (01)08714729087403(17)20190831(10)19642834
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 03/07/2017

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 Expiration Date: 08/31/2019
• Device Model Number: M0063301060
• Device Catalogue Number: 330-106
• Device Lot Number: 19642834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 06/30/2017
• 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