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

Model Number M00535150

Device Problems Break (1069); Failure to Align (2522); Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 01/06/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a stonetome was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noticed that "the axis of the nipple did not fit well with the device, so torque was applied to the device to turn it in the axial direction.Then, when the knife was pulled out, it twisted along with the catheter, which resulted in a different orientation and angle than normal.The knife part was separated while trying to turn it back".It was reported that no part of the cutting wire detached and fell into the patient.Additionally, it was reported that an attempt was made to cut through stones.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned stonetome was analyzed, and a visual evaluation noted that the cutting wire was broken at the proximal pierced hole.It was also found that the working length was twisted.The device was observed under magnification and the cutting wire was broken and blackened.A functional evaluation for orientation and the bowing function could not be performed due to the broken cutting wire.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if the cutting wire was activated before use which may cause premature cutting wire fatigue and compromise the cutting wire's integrity.Also, if energization was applied to the device constantly or activated in an incorrect position, being in contact with other medical devices.It was also found that the working length was twisted which could have been generated if the device was rotated without the tip fully exited the scope.Additionally, handling and manipulation of the device during unpacking/prepping/testing can lead to a twist in the working length.Based on all gathered information, 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.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 stonetome was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noticed that "the axis of the nipple did not fit well with the device, so torque was applied to the device to turn it in the axial direction.Then, when the knife was pulled out, it twisted along with the catheter, which resulted in a different orientation and angle than normal.The knife part was separated while trying to turn it back".It was reported that no part of the cutting wire detached and fell into the patient.Additionally, it was reported that an attempt was made to cut through stones.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: STONETOME
• Type of Device: 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: 13425298
• MDR Text Key: 289186435
• Report Number: 3005099803-2022-00351
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: 08714729146667
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 0027491292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• 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