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

Model Number M0063903010

Device Problems Break (1069); Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection found the working length is kinked in the proximal section.The device was received with the basket opened.Functional inspection found the thumb wheel would move freely in both directions; however, the basket did not move.Device was disassembled and found the pull wire had been broken at the proximal end.The broken section shows evidence of bending.With all the available information, boston scientific concludes that handling and manipulation of the device during its use or testing and interaction with the scope or other devices could resulted in the working length kinking.Moreover, the pull wire breaking could have been caused due to the force applied to the handle to rotate the basket during preparation.The broken section of the pull wire had evidence of bending, indicating the device was submitted to bending forces which could have contributed to the breakage, affecting the device's function to open/close the basket properly.Additionally, the device was not used in accordance with the dfu/labeling, as the device was used on (b)(6) 2019, but the expiration date on the labeling states the device expired on (b)(6) 2019.Based on all available information, the most probable root cause is failure to follow instructions.A labeling review was performed, and from the information available, this device was not used per the directions for use (dfu)/labeling as the product was expired when used.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 Description

It was reported to boston scientific corporation that an optiflex retrieval basket was used in the ureter during a flexible ureteroscopy (f-urs) procedure performed on (b)(6) 2019.According to the complainant, prior to procedure, the device was inspected and found the basket failed to open.The procedure was completed with a different device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reportedly stable.The investigation found that the pull wire was detached.

• Brand Name: OPTIFLEX
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9774940
• MDR Text Key: 190638356
• Report Number: 3005099803-2020-00577
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2019
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0020975528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1