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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A photo submitted by the customer of the device inside its pouch packaging was reviewed and found no issues.Visual analysis of the returned device found the basket was partially extended when received, and the working length was bent from the handle.Functional inspection found the thumb wheel was able to move freely in both directions; however, 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 bending was observed at the broken end.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and integrity.Handling and manipulation of the device can lead to kinking of the working length.The kinks in the working length can cause issues in rotating the basket due to the wire being unable to rotate freely in the kinked area.The pull wire breaking could have been caused due to the force applied to the handle after multiple attempts to rotate the basket.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 ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during procedure, the basket opened inside the patient but failed to close.Another optiflex basket was used to complete the procedure.There were no patient complications reported as a result of this event.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: 11280754
• Report Number: 3005099803-2021-00296
• Device Sequence Number: 14125516
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• 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): 02/04/2021

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: 07/15/2022
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0025719546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1