MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER OPTIFLEX¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063903010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device component code relates to device problem code for the investigation results of pull wire broken.A visual analysis of the returned device found that the sheath was kinked at the proximal end (near to the handle) and buckled.Additionally, the pull wire was broken and kinked from the handle cannula.Functional inspection was performed and found that the basket would not open.It is possible that the way in which the device was handled and manipulated during procedure may have contributed to the failures noted.Moreover, the failures found (sheath kinked/buckled, pull wire kinked/broken) could have been caused due to the excessive force or twisting of the device by the user and affected the device's ability to extend the basket.Based on the information available, the most probable cause of this complaint is operational context, probably due to anatomical/procedural factors encountered during the procedure, performance was limited.The device history record review found the device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex¿ nitinol retrieval basket was used in the kidney during a ureteroscopy procedure with stone removal performed on (b)(6) 2018.According to the complainant, during the procedure, the basket could not be opened and closed freely.The stone was within 2 cm and was located in upper ureter, renal pelvis and calyx.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; pull wire broken.

• Brand Name: OPTIFLEX¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7324504
• Report Number: 3005099803-2018-00638
• Device Sequence Number: 109879
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 02/23/2018

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: 04/30/2018
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 19107513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 55