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

Model Number M00546610

Device Problems Defective Device (2588); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 ii access & delivery catheter was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on unknown date.During the procedure, problem was noted against spyscope ds ii catheter.The procedure was not completed due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

Note: this report pertains to a spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2021.During the procedure, the image malfunctioned once the spyscope ds ii was introduced into the duodenoscope, then the image freezed.The image works when it was tested outside the duodenoscope and the problem re-occur as soon as the spyscope ds ii catheter was put back inside the endoscope.A temporary biliary stent was placed inside the patient.The procedure was not completed and was rescheduled in six weeks in order to remove the last gallstone using a spyglass with a boston technical support.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: additional information: block b3, b5 and h6 (device and impact codes) have been updated based on additional information received december 17, 2021.

Manufacturer Narrative

Block h6 (impact codes): impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that there were signs of use in the form of elevator marks 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 for visualization was performed.The device was plugged into the controller.A live, clear image was displayed.No issues 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) or thru-silicon vias (tsvs).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, indicating that 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 has been completed.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

Note: this report pertains to a spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the image malfunctioned once the spyscope ds ii was introduced into the duodenoscope, then the image freezed.The image works when it was tested outside the duodenoscope and the problem re-occur as soon as the spyscope ds ii catheter was put back inside the endoscope.A temporary biliary stent was placed inside the patient.The procedure was not completed and was rescheduled in six weeks in order to remove the last gallstone using a spyglass with a boston technical support.There were no patient complications reported as a result of this event.

• 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: 13110028
• MDR Text Key: 287555862
• Report Number: 3005099803-2021-08024
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

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: 09/08/2023
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0027985382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/17/2021; 02/13/2022
• Supplement Dates FDA Received: 01/13/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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