MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

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).A visual assessment was performed.Only the detached working channel sleeve (wcs) was returned, and appears stretched.The reported complaint of device entrapment of device or device component was confirmed, and specifically analyzed as spyscope detached/separated to address the detached working channel sleeve.It is possible that operational factors, such as user technique/handling, patient anatomy, and accessory use, contributed to the reported complaint, however it is unknown what caused the wcs component to detach from the spyscope ds device.Based on all gathered information, the complaint investigation conclusion code selected is cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr (device history record) review on the most probable lots did not identify any deviations in the manufacturing processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, an ehl probe was stuck in the spyscope ds.When they tried to remove it, a piece of the ehl probe broke off and they were able to remove the piece with forceps.The procedure was completed using another ehl probe.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation finding: detached working channel sleeve.

• Brand Name: SPYSCOPE DS
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8445256
• MDR Text Key: 139606712
• Report Number: 3005099803-2019-01436
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2019

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: M00546600
• Device Catalogue Number: 4660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/22/2019
• 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