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	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).(b)(4).Visual examination revealed the basket was returned in an open position.Functional inspection found the thumbwheel was able to move 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 found the sheath and pull wire were broken near the handle cannula.The broken portion has evidence of torsion and bending.Based on all available information, the failures of the sheath and pull wire being broken could have been generated due to the handling and manipulation of the device during preparation.The broken section has evidence of torsion and bending which indicates that attempts were made to rotate the basket by using the knob on the handle with the basket being held stationary.Continued attempts to actuate the handle or force applied to the handle/sheath could result in the issue of sheath torn and impacting the performance of the basket generating the reported complaint issue of basket failure to open.Therefore, the most probable root cause is adverse event related to procedure.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 ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during preparation, the optiflex basket was tested.The basket was found to have opened and closed at first but it failed to open on the second time.The procedure was completed with another optiflex basket.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.Investigation results revealed that the pull wire is broken; therefore, this is now an mdr reportable event.Please see for full investigation details.

• 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: 10138275
• Report Number: 3005099803-2020-02199
• Device Sequence Number: 11212560
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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 Expiration Date: 04/08/2020
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0021963342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• 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
• Patient Age: 56 YR
• Patient Weight: 60