MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063902010

Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the returned device found that the shrink tube section was kinked/bent.The handle was disassembled to inspect the internal components; and it was found that the sheath was torn and buckled inside the shrink tube, and the pull was broken.The broken ends were inspected under magnification and it was observed that there was kinking on both broken ends.Therefore, the customer complaint of the pull wire being bent was confirmed.Based on all available information, it is most likely that handling and manipulation of the device during its use could have kinked the device at the proximal section.Operational factors, such as user technique while removing the device from its tray, could have kinked the device.Once it is kinked, it can cause friction between the components during the handle actuation.Continued attempts to extend/retract the basket can tear and buckle the sheath and force to actuate the device could have resulted in breakage on where the pull wire was kinked.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that an escape basket was used in urinary tract during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2020.According to the complainant, when the device was unpacked, the working length pull wire was found to be bent and the basket could not be opened or closed.The procedure was completed with another escape basket.There were no patient complications reported as a result of this event.The patient's condition post procedure was reported to be stable.The investigation results revealed that the pull wire was broken; therefore, this is now an mdr reportable event.

• Brand Name: ESCAPE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10864260
• MDR Text Key: 225874746
• Report Number: 3005099803-2020-05317
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: M0063902010
• Device Catalogue Number: 390-201
• Device Lot Number: 0025242938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• 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