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)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gemini¿ stone retrieval basket was used during a ureterolithotripsy procedure performed on (b)(6) 2017.According to the complainant, during procedure, the gemini¿ basket broke and did not work.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".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.
Event or Problem Description
It was reported to boston scientific corporation that a gemini¿ stone retrieval basket was used during a ureterolithotripsy procedure performed on (b)(6) 2017.According to the complainant, during procedure, the gemini¿ basket broke and did not work.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".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 information received as of october 17, 2017.It was noted that the basket was unable to open and one of the basket wire was broken.Additionally, the broken basket wire is still attached at one end.
Additional Manufacturer Narrative
Investigation results: a gemini basket was returned for analysis.A visual evaluation of the returned device found that the sheath was torn at the proximal end.The handle cannula was detached from the proximal end of the handle.Additionally, torque marks was present on the handle cap indicating proper torque during assembly, and indentation marks were found in the handle indicating correct assembly during the manufacturing process.No other issues were noted.The basket section was specifically inspected and no defects or damages were noted.The basket wires were found properly attached to the proximal end of the basket.Due to its condition, functional testing was not performed.The complaint of wire broke, was not confirmed.Based on the findings of the investigation revealing that the device had the handle cannula detached, and sheath torn, the root cause of this event was determined to be 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 confirmed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a gemini¿ stone retrieval basket was used during a ureterolithotripsy procedure performed on (b)(6) 2017.According to the complainant, during procedure, the gemini¿ basket broke and did not work.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".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 information received as of october 17, 2017.It was noted that the basket was unable to open and one of the basket wire was broken.Additionally, the broken basket wire is still attached at one end.

• 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: 6955509
• Report Number: 3005099803-2017-03119
• Device Sequence Number: 19057256
• Product Code: FFL
• UDI-Device Identifier: 08714729074304
• UDI-Public: 08714729074304
• 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,Followup
• Report Date (Section B): 09/21/2017

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: 04/20/2020
• Device Model Number: M0063303060
• Device Catalogue Number: 330-306
• Device Lot Number: 20550036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 10/17/2017; 04/19/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 11/10/2017; 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1