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

Model Number	M0063903010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 inspection of the returned device found that the basket was opened when received and the working length was bent.Functional inspection was performed and found that the thumb wheel moved freely in both directions; however, the basket would not open or close.The device was disassembled, and the pull wire was found broken at the proximal end.The broken end of the pull wire has evidence of torsion.Based on all available information, it is probable that procedural and/or anatomical factors encountered during the procedure could have affected the device performance and integrity.Handling and manipulation of the device and interaction with the scope and other devices could have contributed to the failure of working length bent.Moreover, the broken pull wire could have been caused by the force applied to the handle in order to rotate the basket.The broken end of the pull wire has evidence that indicates the device was submitted to torsion forces, which could have contributed to the breakage and affected the device's ability to open or close the basket properly.Therefore, the most probable root cause of this event 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) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex retrieval basket was used during a transurethral lithotripsy (tul) procedure performed on an unknown date.According to the complainant, during the procedure, the basket failed to open.Reportedly, the handle would not move at all.Another optiflex basket was used to complete the procedure.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation results; pull wire broken.

• 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: 9268151
• Report Number: 3005099803-2019-05368
• Device Sequence Number: 1951346
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/01/2019

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: 02/03/2021
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0023292920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1