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

Model Number	M0063903000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual analysis of the returned device found that the basket was in an extended position when received and does not have visual defects.A functional test was performed and it was found that the thumbwheel would move freely in both directions.However, the sheath would not move over the wire and the basket would not close.When the device was disassembled, it was found that the pull wire was broken at its proximal end.The evaluation concluded that during preparation the device could have been manipulated.Moreover, the failure found (pull wire broken) could have been caused due to the excessive force or twisting of the device by the user.It appears that the encountered failure could have affected the device performance (the ability of the device to retract the basket).Based on the information available and the condition of the returned product it is possible that the way in which the device was handled and manipulated during preparation may have contributed to the failure noted, therefore the most probable root cause of this complaint is ¿handling damage¿.The device history record (dhr) review found that the device met all manufacturing specifications.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 an optiflex nitinol retrieval basket was used during a procedure for sialolithiasis performed on (b)(6) 2017.According to the complainant, during preparation, the optiflex basket was tested and it was found that the basket would not open.The procedure was completed with another optiflex basket.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; pull wire broken.

• Brand Name: OPTIFLEX¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7063130
• Report Number: 3005099803-2017-03512
• Device Sequence Number: 1461442
• Product Code: FFL
• UDI-Device Identifier: 08714729767596
• UDI-Public: 08714729767596
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/09/2017

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: 05/08/2019
• Device Model Number: M0063903000
• Device Catalogue Number: 390-300
• Device Lot Number: 20612569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1