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

Model Number	M0063301110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was used for a ureteroscopy procedure in the ureter on (b)(6) 2017.According to the complainant during the procedure the tip of the basket detached in the ureter.The detached piece was removed from the patient.The procedure was completed by using another gemini 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 "fine".
Additional Manufacturer Narrative
A visual examination of the returned device revealed that the sheath was kinked at 15cm from its distal end.The pull wire was found to be kinked at the same area of the sheath and broken at its distal end.The rest of the pull wire and the basket were not present and not returned for inspection.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.The failures found could have been generated by the manipulation of the device, the interaction with the scope, or the interaction with other devices.These types of failures are consistent with ones caused when the product is being pulled/pushed with excessive force.This may cause damage, deformities, or cause the device to break.Therefore, the most probable root cause for this event is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, the performance of the device was limited.A review of the device history record (dhr) confirmed that the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified batch.A labeling review was performed and no anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was used for a ureteroscopy procedure in the ureter on (b)(6) 2017.According to the complainant during the procedure the tip of the basket detached in the ureter.The detached piece was removed from the patient.The procedure was completed by using another gemini 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 "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: 6579944
• Report Number: 3005099803-2017-01490
• Device Sequence Number: 10792840
• Product Code: FFL
• UDI-Device Identifier: 08714729043379
• UDI-Public: (01)08714729043379(17)20200131(10)20210574
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/28/2017

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: 01/31/2020
• Device Model Number: M0063301110
• Device Catalogue Number: 330-111
• Device Lot Number: 20210574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 06/21/2017
• 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