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 Consequences Or Impact To Patient (2199)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) relates to the (b)(4) for the reported event of basket wire broken.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 ureter during a ureteroscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the basket wire broke off inside the patient.The broken piece was retrieved using biopsy cups.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 fine.
Additional Manufacturer Narrative
A visual analysis of the returned device found that the pull wire was broken and bent from the distal end of the basket cannula.Moreover, three basket wires were broken and discolored consistent with those that were contacted by laser.The evaluation revealed that the pull wire was bent and broken.It is possible that during the procedure, the device could have been manipulated since the failure found (pull wire broken and bent) are issues that could have been generated by manipulation of the device, interaction with the scope or with other devices.During manufacturing the units are inspected to ensure that all finished devices meet specifications.It is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.Therefore, the most probably root cause assigned to the complaint is "operational context".The evaluation also confirmed that the wires were broken and discolored consistent with those that were contacted by laser.It is possible that the reported failure (wire broke) was caused due to an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.Therefore, the most probably root cause assigned to this complaint will be documented as "user error." a review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and, from the information available, the device was not used according to the dfu.
Event or Problem Description
It was reported to boston scientific corporation that a gemini¿ basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the basket wire broke off inside the patient.The broken piece was retrieved using biopsy cups.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 fine.

• 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: 6196523
• Report Number: 3005099803-2016-04033
• Device Sequence Number: 1110863
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: (01)08714729087410(17)20191031(10)19820575
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 12/05/2016

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: 10/31/2019
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 19820575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/31/2017
• 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