MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number M0063903200

Device Problems Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned stone cone was analyzed, and a visual evaluation noted that a burnt spot was observed on the blue outer sheath, approximately 3cm from the distal tip of the sheath.It is likely that the burnt spot on the sheath is a result of a laser damage.A bent was also observed at the burnt spot.The device was actuated and observed that it was difficult to straighten the coil, likely because of the burnt sheath.No other problems with the device were noted.The reported event was confirmed.Based on all available information, the investigation concluded that the interaction between the user and device during the procedure may have contributed to the error.Therefore, the most probable root cause is unintended use error.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a nitinol retrieval coil was used in the ureter during a lithotripsy procedure on (b)(6) 2021.After the procedure, when the stone cone was removed, there was difficulty noted in straightening the coil.When the device was tested outside of the patient during preparation, no problems were observed.The investigation results revealed that the sheath was torn at the distal section; therefore, this is now an mdr reportable event.

• Brand Name: STONE CONE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12150840
• MDR Text Key: 261019263
• Report Number: 3005099803-2021-03405
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005985936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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