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 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

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 ds access & delivery catheter was used in the bile duct during a stone removal with electrohydraulic lithotripsy (ehl) probe performed on (b)(6) 2017.According to the complainant, during the procedure, a non - bsc electrohydraulic lithotripsy (ehl) probe was advanced through the spyscope ds and it was noticed on the monitor that the working channel sleeve was protruding at the distal end.The spyscope ds was removed from the patient and checked; it was confirmed that the working channel sleeve protruded.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

Visual examination of the spyscope ds was performed.There was no protrusion of the working channel sleeve; the working channel sleeve appeared to have been removed and was not returned for analysis.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 catheter was cut open to expose the working channel sleeve; no working channel sleeve was present.The catheter was pulled back to assess the pebax.There was evidence of adhesion of the working channel sleeve to the inside of the catheter, as seen by the faint imprint left by the working channel sleeve braid pattern and the discoloration on the pebax.The complaint was consistent with the reported event of the working channel sleeve protrusion.Additionally, the working channel sleeve was removed and not returned.The working channel sleeve protrusion and working channel sleeve removal 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 ds access & delivery catheter was used in the bile duct during a stone removal with electrohydraulic lithotripsy (ehl) probe performed on (b)(6) 2017.According to the complainant, during the procedure, a non - bsc electrohydraulic lithotripsy (ehl) probe was advanced through the spyscope ds and it was noticed on the monitor that the working channel sleeve was protruding at the distal end.The spyscope ds was removed from the patient and checked; it was confirmed that the working channel sleeve protruded.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: 6713217
• MDR Text Key: 80036347
• Report Number: 3005099803-2017-01976
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20181231(10)20081725
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

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: 12/31/2018
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 20081725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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