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

Model Number 390-320

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a stone cone was to be used in the common bile duct during a ureterolithotomy procedure to be performed on (b)(6) 2023.During the preparation, it was observed that the inner packaging of the device was not properly sealed when the hospital staff opened the outer plastic packaging for the procedure.As a result, the sterility requirement could not be met.There were no patient complications reported as a result of this event.

Manufacturer Narrative

E1: initial reporter facility name: the fourth affiliated hospital of china medical university block h6: imdrf device code a020503 captures the reportable event of when the hospital staff opened the outer plastic packaging of the device to perform the procedure, it was found that the inner packaging of the device was not well sealed.Sterility could not be satisfied.

Event Description

It was reported to boston scientific corporation that a stone cone was to be used in the common bile duct during a ureterolithotomy procedure to be performed on may 30, 2023.During the preparation, it was observed that the inner packaging of the device was not properly sealed when the hospital staff opened the outer plastic packaging for the procedure.As a result, the sterility requirement could not be met.The procedure was completed with another stone cone.There were no patient complications reported as a result of this event.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Block h6: imdrf device code a020503 captures the reportable event of when the hospital staff opened the outer plastic packaging of the device to perform the procedure, it was found that the inner packaging of the device was not well sealed.Sterility could not be satisfied.Block h10: visual inspection of the returned device found that the device did not find any defects, the device was able to close and open.The reported complaint could not be confirmed due to the packaging was not being received.Therefore, the most probable root cause is cause not established which indicates the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.

• 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: 17163717
• MDR Text Key: 318107818
• Report Number: 3005099803-2023-03295
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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: 05/30/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/23/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 83 KG