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

Model Number	M0063301100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(b)(4).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 stone retrieval basket was used in the ureter for ureteral lithotomy under rigid ureteroscopic procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the wire of the basket was detached.The procedure was completed with 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 stable.
Additional Manufacturer Narrative
A gemini basket was received for analysis.A visual evaluation of the device revealed that the basket was in opened/extended position when received.The basket wires were present; one basket wire had been broken.Under examination the broken end of the basket wire was melted, discolored, and the unit has some blackened marks on the basket body which is consistent with devices that were in contact with laser.The broken wire was still attached to the proximal end of the basket.No other issue was noted.The complaint that the wire broke was confirmed.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the directions for use (dfu)/product label.The dfu states "this device must not come in contact with any electrified instrument.This device should not be directly fired upon by a pulsed dye laser.To do so may damage the device and could result in patient injury".Although, the complaint information states that the issue was noted during unpacking/outside the patient; based on the information collected, the analysis performed to the returned device and taking into consideration the dfu instructions, it is the most probable that the reported failure occurred during the use/manipulation of the device and 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 probable cause for this complaint will be documented as " user / use error ".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.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was used in the ureter for ureteral lithotomy under rigid ureteroscopic procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the wire of the basket was detached.The procedure was completed with 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 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: 7537340
• Report Number: 3005099803-2018-01602
• Device Sequence Number: 13524066
• Product Code: FFL
• UDI-Device Identifier: 08714729087427
• UDI-Public: 08714729087427
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 05/04/2018

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: 01/16/2021
• Device Model Number: M0063301100
• Device Catalogue Number: 330-110
• Device Lot Number: 21620416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1