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 Patient Involvement (2645)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope ds access & delivery catheter was used during a design validation study procedure performed on (b)(6) 2017.According to the complainant, during a study procedure, the interior working channel sleeve began protruding inside the human biliary system model.The procedure was completed with another spyscope ds access & delivery catheter.The spyscope ds access and delivery catheter is indicated for single use; however, as part of this bench top study this spyscope was previously used for several study procedures using the human biliary system model.No patient was involved, only a human biliary system model was used.

Manufacturer Narrative

A visual examination of the spyscope ds device found the working channel sleeve extended from the distal cap when received.The tip of the protruded sleeve was frayed.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.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 working channel sleeve did not fall out; the working channel sleeve was pulled out of the catheter.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 remaining attached to the pebax and some discoloration/adhesive on the pebax.The complaint was consistent with the reported event of the working channel sleeve protrusion.Most likely, the defect was due to anatomical/procedural factors encountered during the procedure, therefore, the most probable root cause for the working channel protrusion 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 ds access & delivery catheter was used during a design validation study procedure performed on 20sep2017.According to the complainant, during a study procedure, the interior working channel sleeve began protruding inside the human biliary system model.The procedure was completed with another spyscope ds access & delivery catheter.The spyscope ds access and delivery catheter is indicated for single use; however, as part of this bench top study this spyscope was previously used for several study procedures using the human biliary system model.No patient was involved, only a human biliary system model was used.

• 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: 6956349
• MDR Text Key: 90402443
• Report Number: 3005099803-2017-03007
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

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: 10/31/2018
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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