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

Model Number	M0063301080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Component code relates to device code for the reported event of basket wire broke.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 basket was used in the kidney during a flexible ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the proximal metal tip was detached from the device and remained inside the kidney.The procedure was extended for twenty minutes to successfully retrieve the detached metal tip.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation results: a gemini basket was returned for evaluation.A visual evaluation of the returned device found that the wire was broken.The distal section of the sheath was kinked/ bent in several locations.The distal section of the wires assembly was detached from the device.It was found broken at the splice cannula notch and the wires in the detached section were kinked/bent in several locations.The complaint was confirmed.The evaluation concluded that during the procedure excessive manipulation of the device and interaction with the scope or other devices most likely contributed to the failures (sheath/wires assembly kinked/bent, wires assembly detached) found.Procedural or anatomical or procedural factors encountered during procedure could have affected the device performance and its integrity.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.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was used in the kidney during a flexible ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the proximal metal tip was detached from the device and remained inside the kidney.The procedure was extended for twenty minutes to successfully retrieve the detached metal tip.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report 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: 7127741
• Report Number: 3005099803-2017-03733
• Device Sequence Number: 16510606
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: 08714729087410
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 08/08/2020
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 20985857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 08/08/2018
• 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