MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER OPTIFLEX¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063903010

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(b)(4).A visual analysis of the returned device found that the basket was partially extended when received.The introducer was not returned.A functional test was performed and it was found that the thumbwheel would move freely in both directions.However, sheath would not move over the wire and the basket would not completely open, would not close, and unable to rotate.The device was disassembled and found that the pull wire and a small section of the sheath were broken near the handle cannula within the rack section.The evaluation concluded that during preparation the device could have been manipulated.Moreover, the failure pull wire broken could have been caused due to the excessive force or twisting of the device by the user.It appears that the encountered failure could have affected the ability of the device to extend/retract/rotate the basket.Based on the information available and the condition of the returned product it is possible that the way in which the device was handled and manipulated during preparation may have contributed to the failure noted, therefore the most probable root cause of this complaint is ¿handling damage¿.The device history record (dhr) review found that the device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that an optiflex stone retrieval basket was used during a panedoscopy procedure performed on (b)(6) 2017.According to the complainant, during preparation, the optiflex basket was tested and it was found that the basket failed to open and would not rotate.The procedure was completed with 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 stable.This event has been deemed a reportable event based on the investigation results; pull wire breaks.

• Brand Name: OPTIFLEX¿
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7063747
• MDR Text Key: 93310764
• Report Number: 3005099803-2017-03516
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 19828385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1