MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME - SPHINCTEROTOMES; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date of receipt.The complainant was unable to report the upn and lot number; therefore the unique identifier (udi) #, manufacture date, and expiration date are unknown.(b)(4).The returned autotome was analyzed, and a visual evaluation noted that the cutting wire was detached, bent and blackened.Additionally, the working length was bent/kinked in three sections disabling the device performance.Based on the analysis of the returned device, the cutting wire was detached, bent and blackened.It is most likely that a peak of voltage could have caused the failures noted or if the device was not in contact with the tissue when it was energized.Additionally, working length bent could be caused during insertion into the scope if was not using short and deliberate movements; however there is no control in how devices are handled in the field.Therefore, the most probable cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing records and ship history could not be performed since the batch number, upn and customer number was not reported.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

Boston scientific received an autotome device with no associated information.This event has been deemed reportable based on the investigation results: cutting wire detached.Boston scientific has been unable to obtain additional regarding the event to date, despite good faith efforts.

• Brand Name: AUTOTOME - SPHINCTEROTOMES
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10115180
• MDR Text Key: 194642596
• Report Number: 3005099803-2020-02048
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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