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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the bile duct during a cholangioscopy and biopsy procedures performed for the treatment of cholangiocarcinoma on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was not displayed from the start.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 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 elevator marks on the shaft of the catheter.An image assessment for visualization was performed.Upon plugging the device into the controller, a live image was displayed.Articulation of the catheter had no effect on image.Interaction with the umbilicus cable would cause image to be disrupted; the initialization screen appeared followed by loss of image.Reinsertion of the umbilicus into the controller would intermittently bring an image; some reinsertions would produce a live image while other reinsertions did not.X-ray imaging of the distal tip and handle showed no anomalies.The handle was opened and the electrical components inside were inspected visually.Visual assessment showed no problems with the glue feature.The bond of the glue feature to the pcba was inspected there was no impact to image seen.The umbilicus of the device was replaced with a known working umbilicus and a live image was displayed even after interaction with the umbilicus cable.The umbilicus connector was inspected, and potential adhesive was found on one of the umbilicus pads.Based on the position of the witness marks on the umbilicus pads, it is likely that the adhesive may have blocked the pins of the controller from contacting the umbilicus pad.Material testing in the form of fourier-transform infrared spectroscopy (ftir) confirmed that the adhesive on the umbilicus pad matched the spectrum for adhesive that is used during manufacturing.The reported event was confirmed.During product analysis, it was noted that the failure was caused by foreign material on the umbilicus pcba pad.The foreign material most likely came from the manufacturing process, as ftir testing confirmed the material to be the same as glue used in production.It is possible that this glue dripped on this location during production and only cured to the point communication between the scope and controller was inhibited after production was complete.The unit had calibration data that occurs at the end of production and all image testing passed during production for the batch; indicating the residue wasn't fully cured during production which allowed the device to be calibrated and pass inspection.The final inspection lists a step to wipe the umbilicus board with an alcohol-soaked foam tipped swab to remove any residue.Given the characteristics of the adhesive/ glue used during manufacturing; it is unlikely that this swab would be effective in removing all of the adhesive if found and it is also possible that the adhesive deposited onto the pcba pad after this process step.Therefore, it can be said that inadequate inspection steps have allowed a defective device to reach the user.Based on all gathered information, the probable cause selected for the visualization problem due to glue on the umbilicus pcba is quality control deficiency.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: correction to block e1 (initial reporter address 1).Correction to block e1 (initial reporter address 2).

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the bile duct during a cholangioscopy and biopsy procedures performed for the treatment of cholangiocarcinoma on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was not displayed from the start.The procedure was not completed due to this event.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: 18287009
• MDR Text Key: 330016566
• Report Number: 3005099803-2023-06493
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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 Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0032386691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• 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