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	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).Visual analysis of the returned device found the basket was opened when received.Functional inspection was performed and found the thumb wheel will move freely in both directions; however, the basket failed to close.The device was disassembled, finding the pull wire had been broken at the proximal end.The broken ends have evidence of bending.As per complaint information, the issue occurred during the procedure.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity, or during the procedure the device could have been manipulated.Moreover, the broken pull wire could have been caused due to the force applied to the handle in order to rotate the basket.The broken end of the pull wire had evidence of bending indicating the device was submitted to bending forces which could have contributed with the breakage and it affected the device's ability to open/close the basket properly.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex retrieval basket was used in the kidney during an retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the basket failed to open.The procedure was completed with a different device.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results, pull wire detached/separated.

• 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: 9100757
• Report Number: 3005099803-2019-04657
• Device Sequence Number: 14183895
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 09/20/2019

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 Model Number: M0063903010
• Device Catalogue Number: 390-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR