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

Model Number 390-320

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Device code a040506 captures the reportable event of the attached wire torquer was found to be damaged.

Event Description

It was reported to boston scientific corporation that a stone cone baskets was used on a transurethral lithotomy (tul) procedure performed on (b)(6) 2023.During procedure, the attached wire torquer was found to be damaged.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code a040506 captures the reportable event of the attached wire torquer was found to be damaged.Block h10: visual inspection of the returned device found that the white and blue heat shrink were accordioned.During the functional test, it was observed that the cone could not be closed.The reported complaint is confirmed.Based on all available information, it is most likely that the damage was caused during the test of the device with the use of excessive force or manipulation.When force was exerted, the white and blue sheath became accordioned ultimately making it difficult to properly close the coil.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 stone cone baskets was used on a transurethral lithotomy (tul) procedure performed on (b)(6) 2023.During procedure, the attached wire torquer was found to be damaged.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.Investigation results revealed the sheath bucked accordion; therefore, this is now a non mdr reportable event (see block h10 for investigation details).

• 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16581934
• MDR Text Key: 312041992
• Report Number: 3005099803-2023-01438
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• 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: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 390-320
• Device Catalogue Number: 390-320
• Device Lot Number: 0006943658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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