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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Visual inspection of the returned device found the basket was in an open position when received and the working length was kinked at the distal end.Functional inspection was performed and found the thumb wheel would move freely in both directions but the basket did not close.The device was disassembled for further investigation and found the pull wire had been broken at its proximal end.Evidence of torsion was observed at the broken end.Based on all available information, handling and manipulation of the device during unpacking, prepping, and/or testing can lead to kinking of the working length, and it could have impacted the overall performance of the device.Moreover, pull wire broken could have been caused by the force applied to the handle in order to rotate the basket.The kinks in the working length can cause issues to rotate the basket, the wire would not rotate freely in the kinked area.Continued attempts to rotate the basket can result in wire breakage.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 an unknown date.After opening the package, the handle was actuated and found the basket does not open or close.Another optiflex basket was used to complete the procedure.There were no patient complications as a result of this event.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: 11362157
• Report Number: 3005099803-2021-00635
• Device Sequence Number: 3383554
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: 10/28/2022
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0026260397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1