MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY

Model Number	M00535150
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the bile duct during an endoscopic bile duct stone removal procedure performed on (b)(6) 2022.During the procedure, the tip of the forming mandrel was detached from the device and fell into the patient.The detached tip was retrieved using a forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and shows the detached tip of the forming mandrel.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Impact code f2301 captures the reportable event of retrieval of the detached forming mandrel tip using a forceps.Medical device problem code a0203 captures the reportable event of forming mandrel tip detached.The returned curving mandrel of the stonetome was analyzed, and a visual evaluation noted that the molding tip was detached from the curving mandrel and it was not returned.Per media analysis, the provided photo showed that the molding tip was detached from the curving mandrel.The curving mandrel was observed under magnification and no visual damage/problem found.Per the dimensional inspection, the thickness and the length of the coined end of the were measured and these were within specifications.No other problems with the device were noted.The reported event of molding tip was detached from the curving mandrel was confirmed.Upon analysis, it was found that the molding tip was detached from the curving mandrel which matches with the findings based on the media inspection; however, it was not returned.Based on the findings, the problem could have been generated due to handling/manipulation upon removal of the mandrel from the stonetome.Therefore, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the bile duct during an endoscopic bile duct stone removal procedure performed on (b)(6) 2022.During the procedure, the tip of the forming mandrel was detached from the device and fell into the patient.The detached tip was retrieved using a forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and shows the detached tip of the forming mandrel.No further information has been obtained despite good faith efforts.

• Brand Name: STONETOME
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15086404
• Report Number: 3005099803-2022-04014
• Device Sequence Number: 19847515
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: 08714729146667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 0027598799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown