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 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

A visual examination of the spyscope ds device found that the working channel sleeve extended from the distal cap when received.The catheter was kinked in several locations on the distal end.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 spyscope ds was plugged into the controller and no issues were identified with the live image.The device was laid out straight and fully articulated in all directions.No issues were identified with the image.A guidewire and a spybite were passed through the working channel, and no issues were identified with the image.A portion of the distal end of the catheter was 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 some force.There was strong evidence of adhesion of the working channel sleeve to the inside of the catheter, as seen by the white area on the proximal end of the pebax and the working channel sleeve braid imprint throughout the pebax region.The complaint was not consistent with the reported event of image loss, however, it was found that the catheter was kinked and the working channel sleeve extended from the distal cap when received.Based on the investigation and the receipt condition/functionality, the most 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.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that a spyscope digital access & delivery catheter was used in the common bile duct during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the spyscope ds image was lost.Reportedly, there was no visible damage noted to the device prior to use.The procedure was completed with another spyscope digital access and delivery 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.This event has been deemed a reportable event based on the investigation results; working channel sleeve protrusion.

• 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: 7152084
• MDR Text Key: 96124428
• Report Number: 3005099803-2017-03717
• 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: 12/01/2017

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: 09/13/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 21129863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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