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

Model Number	M0063903010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection of the returned device found the basket was received closed.The working length was kinked at the distal end.Functional inspection was performed and found the thumb wheel will move freely in both directions but the basket did not open.The device was disassembled and the pull wire was noted to be broken at its proximal end.The broken ends have evidence of bending and torsion.Based on all available information, it is 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 can lead to kink of the working length and could have "inpacted" the overall performance of the device.Moreover, the failure (pull wire broken) could have been due to the force applied to the handle in order to rotate the basket.The broken end of the pull wire showed evidence that the device was submitted to bending and torsion forces which could have contributed with the pull wire breakage, affecting 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 used in the ureter during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the basket became unable to open and was stuck closed.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 reportable based on the investigation results; pull wire detached/separated.

• 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: 9590828
• Report Number: 3005099803-2020-00038
• Device Sequence Number: 328016
• 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): 01/15/2020

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: 05/07/2021
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0023758134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1