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	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual analysis found residues at the wires of the basket indicating use and handling of the device.The working length was kinked at the proximal end.The basket was extended when received.During functional inspection, the thumb wheel moved freely in both directions but the basket did not move.Device was disassembled and found pull wire had been broken at its proximal end.The broken end was inspected and evidence of bending was observed.Based on all available information, it is most likely that procedural or preparation factors encountered could have affected the device performance and its integrity.Handling and manipulation of the device can lead to the device kinking.The pull wire breaking could have been due to the force applied to the handle to rotate the basket, as the broken end of the pull wire had evidence of bending indicating that the device was submitted to bending forces.This failure could have affected the device's ability to open or 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.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex retrieval basket was to be used in the kidney during a flexible ureteroscope lithotripsy procedure performed on (b)(6) 2020.According to the complainant, during preparation, the basket failed to open.Another optiflex basket was used to complete the procedure.There were no patient complications reported 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 detached/separated; 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: 10770534
• Report Number: 3005099803-2020-04947
• Device Sequence Number: 14475622
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/02/2020

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: 04/29/2022
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0025480713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 74