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

Model Number	M0063903010
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection of the returned device found that the device does not have any visual damage.During evaluation, the device was disassembled and found that the wire was broken and a bend was found at the broken end of the wire.Under uv light and magnification, residues of glue were observed on the cannula and punch vise.The rack gear was checked under x-ray and the pull wire was noted to be kinked and broken.Additionally, the thumb wheel could not be moved during functional inspection causing the basket not to open properly.Based on the information available and the analysis performed, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse 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.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex retrieval basket was used in the ureter during a ureterolithiasis procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the handle wheel of the basket could not be rotated, and the physician's hand was hurt while actuating as a result.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition post procedure was reported to be stable.Investigation results revealed that 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: 9900520
• Report Number: 3005099803-2020-01346
• Device Sequence Number: 2238365
• 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): 03/30/2020

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: 07/08/2021
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0024077607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60