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 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The patient was over the age of 18.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during an oral cholangioscope procedure performed on (b)(6) 2016.According to the complainant, during the procedure, after an endoscopic sphincterotomy (est) was performed, this spyscope ds was inserted over the jagwire guidewire which was inserted inside the bile duct.During the observation of the bile duct, the device was reinserted directly as it came out of the bile duct.It was then noticed that the working channel sleeve was protruding which was checked and confirmed after it was removed.Reportedly, no part of the device detached and the procedure was completed with a second spyscope ds.There were no patient complications reported as a result of this event.

Manufacturer Narrative

A visual examination of the spyscope ds device found that the working channel sleeve extended from the distal cap when received.The distal tip would articulate without issue.The proximal end of the distal cap was aligned to the cap weld. a spybite device was passed freely through the working channel without issue. the distal end of the exposed working channel sleeve was tugged; it was not detached from the catheter.  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. further evaluation found that there is evidence of adhesion of the working channel sleeve to the inside of the catheter.The complaint was consistent with the reported event of working channel sleeve protruding.Based on the investigation, the date the complaint lot number was built, and the receipt condition/functionality, the most probable root cause for the working channel sleeve protrusion is manufacturing.An investigation addressing this issue has been completed.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 common bile duct (cbd) during an oral cholangioscope procedure performed on (b)(6) 2016.According to the complainant, during the procedure, after an endoscopic sphincterotomy (est) was performed, this spyscope ds was inserted over the jagwire guidewire which was inserted inside the bile duct.During the observation of the bile duct, the device was reinserted directly as it came out of the bile duct.It was then noticed that the working channel sleeve was protruding which was checked and confirmed after it was removed.Reportedly, no part of the device detached and the procedure was completed with a second spyscope ds.There were no patient complications reported as a result of this event.

• 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: 6204000
• MDR Text Key: 63261023
• Report Number: 3005099803-2016-03850
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20180630(10)19338977
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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: 06/30/2018
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 19338977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2016
• 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