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

Model Number M00535150

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a stonetome was used in the papilla during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cutting wire broke.The procedure was completed with a second stonetome.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a stonetome was used in the papilla during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cutting wire broke.The procedure was completed with a second stonetome.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(device codes): the problem code 1069 captures the reportable event of cutting wire broken.Visual examination of the returned device revealed that the cutting wire was broken, bent and blackened, which directly affected the functionality and integrity of the device.The complaint was consistent with the reported event of cutting wire broke.It is most probable that a peak of voltage could have caused the failures found in the device or if the device was not in contact with the tissue when it was energized.Therefore, the event is classified as adverse event related to procedure because of the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.

• Brand Name: STONETOME
• Type of Device: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9268438
• MDR Text Key: 182377858
• Report Number: 3005099803-2019-05369
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: 08714729146667
• Combination Product (y/n): N
• PMA/PMN Number: K946358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/25/2019

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: M00535150
• Device Catalogue Number: 3515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/29/2019
• Supplement Dates FDA Received: 12/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1