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

Model Number	M0063903010
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Difficult to Open or Close (2921); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Visual analysis found the device was returned with the basket overextended.The working length was found kinked at distal end.Functional inspection found the thumb wheel moved freely in both directions, but the basket did not move.The device was disassembled for further investigation and found the pull wire had been broken at its proximal end.The broken end was inspected under magnification and evidence of bending was observed.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during its use can lead to the working length kinking, and it could have impacted the overall performance of the device.Moreover, the pull wire being broken could have been caused due to 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 the device's ability to open/close the basket properly.Therefore, the most probable root cause is adverse event related to procedure.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.A labeling review was performed and, from the information available, this device was not used per the instructions for use (ifu) / product label as the device was expired when used.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex retrieval basket was used in the ureter during a ureterolithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the basket failed to open.Another optiflex basket was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.The investigation results revealed the pull wire was broken; 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: 10666726
• Report Number: 3005099803-2020-04446
• Device Sequence Number: 3903320
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 10/12/2020

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: 02/17/2020
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0021758564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR