MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown.However, the complainant reported that the device was not expired.(b)(4).Visual inspection of the returned device found the basket was in an open position when received.Additionally, a basket wire was found broken.Functional inspection was performed and found the thumbwheel moved freely in both directions.However, the sheath did not move over the wire and the basket was not able to be opened or closed.The device was disassembled and it was observed that the sheath and pull wire were found broken near the handle cannula.The broken portions (sheath and pull wire) have evidence of torsion and bending.Based on all available information, the failure of basket wire broken and sheath/pull wire broken could have been generated due to manipulation of the device during preparation or procedure.Handling and manipulation of the device during the procedure could lead the observed wire break.Additionally, the broken portion has evidence of torsion and bending, which indicates that attempts were made to rotate the basket using the knob on the handle with the basket being held stationary by some means.Continued attempts to actuate the handle or force applied to the handle/sheath could result in the issue of the sheath tearing, impacting the basket's performance.Therefore, the most probable root cause is adverse event related to procedure.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 left kidney during a fiberoptic transurethral lithotripsy (f-tul) procedure performed on (b)(6).According to the complainant, during procedure, the handle suddenly became hard and unable to move.Another optiflex basket was used to complete the procedure.There were no patient complications reported 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: 10140463
• Report Number: 3005099803-2020-02209
• Device Sequence Number: 13978553
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 04/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1