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

Model Number M00546600

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

A visual examination of the spyscope ds device found the working channel sleeve extended from the distal cap when received.The proximal end of the distal cap was aligned to the cap weld.There was evidence of the production bonding process and the application of heat to the outside of the catheter during manufacturing assembly, as seen in the working channel sleeve reflow/bond.A functional inspection was performed.The distal tip articulated without issue.A spybite device was passed through the working channel without issue.A portion of the distal end of the catheter were removed to examine the working channel.The distal cap was removed from the catheter for examination.The distal end of the exposed working channel sleeve was tugged; it was not detached from the catheter.The catheter was cut open to expose the working channel sleeve.The catheter was pulled back to assess the adhesion of the working channel sleeve to the pebax; the last part of the proximal end of the working channel sleeve appeared to be attached to the pebax.The working channel sleeve did not fall out and the working channel sleeve was pulled out of the catheter with force.There was strong evidence of adhesion of the working channel sleeve to the inside of the catheter, as seen by the proximal end of the working channel sleeve braid remaining attached to the pebax and the clear/white area on the proximal end of the pebax, and the working channel sleeve braid imprint throughout the pebax region.The complaint was consistent with the reported event of working channel sleeve protruding.Based on the investigation and the receipt condition/functionality, the probable cause conclusion is "manufacturing process design".There is an investigation in place to address this issue.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 & delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, as the spybite biopsy forceps was advanced through the spyscope ds, it was noticed that the working channel sleeve protruded.Reportedly, no part of the device detached.The procedure was completed with this device.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: 7153115
• MDR Text Key: 96125978
• Report Number: 3005099803-2017-03724
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/04/2017

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: 11/03/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 21338493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1828132-12/22/2017-002-R
• Patient Sequence Number: 1