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); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation analysis: an optiflex retrieval basket was returned for analysis.A visual evaluation of the returned device revealed that the basket was received in a closed position.The sheath was inspected under magnification and it was observed that the sheath was bent/flattened in some locations.No other anomalies were noted.A functional inspection was performed, and found that the thumb wheel moved freely in both directions, however the basket did not open.A further investigation was performed and the device was disassembled, finding the pull wire had been broken at proximal section.The broken end has evidence of bending.As per complaint information the issue occurred after two or three operations during the removal procedure, this indicates that probably the device was returned in good conditions, however procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.It is most likely that during the procedure the device could have been manipulated.Handling and manipulation of the device during its use can lead to bend/flatten the sheath.This condition would reduce the lumen of sheath causing resistance to open/close the basket, continued attempts to open/close the basket can result in pull wire breakage and the device can become inoperable (unable to open/close the basket).Based on the information available and the analysis performed, the conclusion code for the complaint will be documented as "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.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 a opti flex retrieval basket was used in the right ureter for a flexible ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the basket was not able to open due to the handle being unable to move after being utilized two to three times.The basket was reported to be in a closed position when it stopped working.The procedure was completed with another opti flex retrieval basket.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be good.This event has been deemed a reportable event based on the investigation results; pull wire broken.

• 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: 8566626
• Report Number: 3005099803-2019-02293
• Device Sequence Number: 1981760
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/30/2019

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: 07/08/2020
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0022346934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR