MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTIFLEX; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063903010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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.The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Visual analysis of the returned complaint device found the basket was in an opened position.Functional evaluation found the thumb wheel moved freely in both directions; however the basket failed to close.The device was disassembled and found the pull wire had been broken at its proximal end.The broken end has evidence of bending.As per complaint information, the issue occurred during the procedure.Probably procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is most likely that during the procedure, that device could have been manipulated.Moreover, the issue of pull wire broken could have been caused due to the force applied to the handle in order to rotate the basket.The broken end of the pull wire had evidence of bending, indicating the device was submitted to bending forces which could have contributed to the breakage and affected the ability of the device to open or close the basket properly.During manufacturing, the thumb wheel is turned to open and close the basket.This inspection would have detected the issue to open/close the basket.However, there is no control how the devices are handle in the field.Therefore, the conclusion code for this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.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.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex retrieval basket was used in a procedure on an unknown date.According to the complainant, during the procedure, the basket failed to open.No patient complications have been reported as a result of this event.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.Investigation results revealed that the pull wire was detached; therefore, this is now an mdr reportable event.

• Brand Name: OPTIFLEX
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8831032
• Report Number: 3005099803-2019-03779
• Device Sequence Number: 335052
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• 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
• Report Date (Section B): 07/26/2019

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: 12/12/2019
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0021504181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1