MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the spyscope ds device found that the distal tip was damaged.It was observed that, the distal cap near the working channel sleeve lumen has broken off; the damaged portion was not returned for analysis.A functional evaluation was performed.The distal tip did not articulate when turning the small knob in the clockwise the direction.A spybite device was passed through the working channel without issue.The handle was disassembled for examination; one of the steering wires was found broken.The complaint was consistent with the reported event that the device did not articulate properly.In addition, it was found that a section of the distal cap was detached.The detachment 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.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 and delivery catheter was used in the common bile duct during a cholangioscopy procedure performed on (b)(6) 2017.According to the complainant, during procedure, the small control knob is not articulating the device.Reportedly, there was no visible damage noted on the spyscope ds.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; tip detached.

• 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: 6768367
• MDR Text Key: 81922845
• Report Number: 3005099803-2017-02409
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20190503(10)20597891
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 07/09/2017

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: 05/03/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 20597891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2017
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• 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