MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problems Detachment Of Device Component (1104); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was under the age of 18.A visual examination of the spyscope ds found that the catheter was kinked in several sections.There was no protrusion of the working channel sleeve observed because the sleeve was not returned.The distal tip would articulate without issue.The proximal end of the distal cap was aligned to the cap weld.A spybite device and a guidewire were passed freely through the working channel without issue.There was evidence that heat was applied on the outside of the catheter during manufacturing assembly.Part of the distal end of the catheter was removed to examine the working channel; no working channel sleeve was present.The distal cap was removed from the catheter for examination.Further evaluation found that there is evidence of adhesion of the working channel sleeve to the inside of the catheter.The working channel sleeve protrusion and working channel sleeve detached was most likely due to anatomical/procedural factors encountered during the procedure; therefore, the most probable root cause is operational context.A dhr (device history record) review was performed and no deviation was found.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the duodenum/bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after taking multiple biopsies, it was noticed that there was difficulty advancing the spybite biopsy forceps through the spyscope ds and the working channel of the spyscope ds protruded at the tip.The device was removed from the patient.Once outside the patient it was noted that the working channel sleeve had detached inside the endoscope and was hanging out of endoscope channel.The detached working channel sleeve was removed from the endoscope and was disposed.The procedure was completed with a second spyscope ds catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SPYSCOPE DS ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6705044
• MDR Text Key: 79785358
• Report Number: 3005099803-2017-02072
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20190430(10)20521154
• 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: 06/15/2017

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 Expiration Date: 04/30/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 20521154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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