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	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: an optiflex retrieval basket was received for analysis.A visual analysis of the returned device revealed that the basket was partially extended when received.The introducer was also returned with the device.The device did not have any visual defects.A functional inspection was performed and found that the thumb wheel moved freely in both directions; however, the sheath would not move over the wire and the basket would not open or close.The device was disassembled and found that the pull wire had been broken at its proximal end.It is the most likely that the device could have been manipulated since the failure, pull wire broken, could have been caused due to the excessive force or twisting of the device by the user and it affected the devices' ability to open/close the basket.Based on the information available, it is possible that the way in which the device was handled and manipulated during procedure may have contributed to the failure.Therefore, the most probable cause of this complaint is "operational context", since probably due to anatomical/procedural factors encountered during the procedure, performance was limited.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.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex¿ retrieval basket was used in the ureter during a left laser lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the basket was unable to open or close inside the patient.The procedure was completed with another opti-flex basket.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 an mdr reportable event based on investigation findings of 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: 7774834
• Report Number: 3005099803-2018-02511
• Device Sequence Number: 19180449
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• 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): 07/23/2018

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: 02/29/2020
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 21807799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR