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 11/21/2016

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 digital access and delivery catheter was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the device was removed from the packaging and no issue were noted with the device.The spyscope ds was then passed smoothly through the duodenoscope.As the spyscope ds exited the duodenoscope it was noticed on the monitor that the working channel sleeve was protruding at the distal end.The physician removed the spyscope ds from the patient and when examined outside the patient the physician confirmed that working channel 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.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).A visual examination of the spyscope ds device found that working channel sleeve was not 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 through the working channel without issue.There was evidence that heat was applied on the outside of the catheter during manufacturing assembly.The complaint is not consistent with the returned spyscope ds since the working channel sleeve was not extended from the distal cap.Therefore, the most probable root cause is "not confirmed." 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 endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the device was removed from the packaging and no issue were noted with the device.The spyscope ds was then passed smoothly through the duodenoscope.As the spyscope ds exited the duodenoscope it was noticed on the monitor that the working channel sleeve was protruding at the distal end.The physician removed the spyscope ds from the patient and when examined outside the patient the physician confirmed that working channel 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.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 6180352
• MDR Text Key: 62541566
• Report Number: 3005099803-2016-03754
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20180630(10)19394587
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 11/21/2016

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: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 19394587
• 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: 11/21/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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
• Patient Age: 42 YR
• Patient Weight: 45