MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) 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)
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).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an optiflex¿ basket was used in an unknown procedure performed on an unknown date.According to the complainant, during the procedure, when the basket was utilized for opening and closing for about twenty times, it would no longer open or close.It was reported that it seemed that the handle and the shaft part got separated.The procedure was completed using a different device.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 "good".

• Brand Name: OPTIFLEX¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7607689
• Report Number: 3005099803-2018-01956
• Device Sequence Number: 1695027
• 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): 05/23/2018

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 Model Number: M0063903010
• Device Catalogue Number: 390-301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1