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 Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An examination of the device revealed the basket was returned in a closed position.Functional inspection found the thumb wheel moved freely in both directions but the basket did not open.Device was disassembled and found the pull wire had been broken at its proximal end.Probably procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is most likely that during the procedure the device could have been manipulated.Moreover, the failure found (pull wire broken) could have been caused due to the excessive force or twisting of the device by the user and it affected the device's ability to open the basket.Based on the information available and the analysis performed, the conclusion code for the complaint will be documented as "cause traced to component failure" since there is an expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex retrieval basket was used during a flexible ureteroscopy procedure performed on (b)(6) 2018 through retrograde access in the kidney to treat stones.According to the complainant, during the procedure it was reported that the handle of the basket was not working and the basket could not be opened.The procedure was completed with another optiflex basket.There was no serious injury nor were there any adverse patient effects reported as a result of this event.This event has been deemed a reportable event based on the investigation results; pull wire detached.

• 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: 8025557
• Report Number: 3005099803-2018-61130
• Device Sequence Number: 11114507
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 10/31/2018

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: 01/17/2020
• Device Model Number: M0063903010
• Device Catalogue Number: 63405
• Device Lot Number: 0021620641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1