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

Model Number M00546610

Device Problem Optical Problem (3001)

Patient Problems Fever (1858); Sepsis (2067)

Event Date 03/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The returned spyscope ds ii was analyzed, and a visual evaluation noted that no elevator marks were noted on the shaft of the catheter.No damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.An image assessment was performed.The device was plugged into the controller.A live, clear image was displayed.No problems were observed with physical connectivity of the device.The umbilicus connector was visually inspected and no damage or defects were noted.The device was fully articulated in all directions; no problems were identified with the image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl), thru-silicon vias (tsvs), or camera wire.X-ray imaging of the handle showed no problems with the printed circuit board assembly (pcba) or camera wires.The handle was opened and the components within were visually inspected.It was noted that there was procedural residue on the plastic optical fibers (pofs) and camera wire in the breakout region, indicated procedural fluids had flowed back up the optics lumen into the handle during use.The tip was blocked and saline was flushed through the irrigation tubing to induce backflow of saline into the optics lumen.This caused the image to be disrupted, with blue/orange lines across the screen and a purple hue, leading to a full loss of image.The saline was drained from the optics lumen and the image was restored.The reported event was confirmed.During product analysis, it was noted that procedural residue remained at the top of the optics lumen in the breakout.The optics lumen was filled with saline and the image was disrupted.Draining the optics lumen resulted in the restoration of the image.The image signal does not withstand the change in capacitance created by the introduction of saline into the optics lumen, and procedural factors can cause this fluid to enter the optics lumen during use.An investigation to address this problem is in progress.Therefore, cause traced to device design is the most probable cause selected for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaint exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the image of the spyscope ds ii was lost a couple of minutes while inside the bile duct.They unplugged and replugged the spyscope ds ii but it did not work.The procedure was completed with a second spyscope ds ii.There were no patient complications reported during the procedure.On (b)(6) 2021, the patient returned to the hospital presenting with sepsis and fever.Laboratory examination showed elevated white blood cells (wbc) count and elevated liver functions test (lft).Antibiotics were administered (ceftriaxone and flagyl) to treat the fever.To treat the sepsis, the old plastic stent was removed, and a balloon procedure was performed.The patient's gallbladder was also removed.The patient was stabilized for cholecystectomy and cholangiogram in early (b)(6).

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11849064
• MDR Text Key: 251422931
• Report Number: 3005099803-2021-02317
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 26859417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 75