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

Model Number M00546610

Device Problems Poor Quality Image (1408); Optical Problem (3001)

Patient Problem Perforation (2001)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.

Event Description

Note: this report pertains to a spyscope ds ii and spybite max biopsy forceps used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used along with a spybite max biopsy forceps during an endoscopic bile duct biopsy procedure performed for the treatment of suspected intrahepatic bile duct cancer on (b)(6) 2023.During the procedure, the patient was scheduled for a biopsy and a specimen was collected from the distal bile duct.When it was about to reach the target porta hepatis, the image of the spyscope ds ii became distorted and was lost after one hour of usage.A second spyscope ds ii was used, and they noticed a bile duct perforation.They were unable to collect the specimen and made a pathological diagnosis.Any forceful or prolonged operations using the device was not performed after two repeated insertions and removals.A surgical intervention was then performed; the physician believed that the perforation was not cause by the spyscope ds ii, but due to the procedural problems that were performed (endoscopic sphincterotomy, endoscopic papillary balloon dilatation and endoscopic papillary large balloon dilation) to the patient.Reportedly, there was no problem with spybite max.There were no future procedures mentioned, and the procedure was completed using another of the same device.The patient's condition at the conclusion of the procedure was reported to be stable and is improving.

Manufacturer Narrative

Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that elevator marks were 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 the image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).No camera wire damage was observed in x-ray imaging of the distal cap.No camera wire damage was observed in the pebax region proximal to the working channel sleeve.X-ray imaging of the handle showed no problems with the breakout region or camera wires around the strain relief.X-ray imaging shows no damage to the camera wires at the printed circuit board assembly (pcba).The handle was opened and the electrical components inside were inspected visually.There was no procedural residue seen near the plastic optic fibers (pof).Visual assessment showed no problems with the glue feature.The bond of the glue feature to the pcba was inspected; tweezers were used to wiggle the glue feature.The connection of the camera wires to the pcba was also inspected by slightly lifting the bottom of the glue feature for each of the four camera wires using the tip of the tweezers.No impact to image was seen after these interactions.A leak test was conducted to determine if a leak path into the optics lumen was present based on the reported loss of visualization.The device was pressurized by injecting fluid through the irrigation port of the device while the distal end was inserted into a mock common bile duct (cbd) fixture.Pressure readings were recorded using a pressure gage and the device was pressurized until a reading was displayed on the gage.Capacitance readings were recorded while the fluid was being injected.No change in either pressure or capacitance was observed.The live image was stable as well and no changes were observed.The reported complaint was not confirmed.During product analysis, a live image was seen upon insertion of the device and after conducting a leak test, no leak was observed; there were no changes to the live image.The device functioned properly throughout testing and no defects were noted.Per the instructions for use (ifu) of the device, adverse events such as perforation during procedure is stated as a possible complication associated with the use of the device.Per the hazard analysis, both events of perforation and additional intervention are listed as potential harms.Therefore, based on all gathered information and related records, the probable cause selected for the reported event is known inherent risk of device, which indicates that the reported adverse event and patient effects are known and documented in the labeling and all reasonable steps have been taken.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: block b5 (describe event or problem) has been corrected.

Event Description

Note: this report pertains to a spyscope ds ii and spybite max biopsy forceps used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used along with a spybite max biopsy forceps during an endoscopic bile duct biopsy procedure performed for the treatment of suspected intrahepatic bile duct cancer on (b)(6) 2023.During the procedure, the patient was scheduled for a biopsy and a specimen was collected from the distal bile duct.When it was about to reach the target porta hepatis, the image of the spyscope ds ii became distorted and was lost after one hour of usage.A second spyscope ds ii was attempted to be used, and they noticed a bile duct perforation.They were unable to collect the specimen and made a pathological diagnosis.Any forceful or prolonged operations using the device was not performed after two repeated insertions and removals.A surgical intervention was then performed; the physician believed that the perforation was not cause by the spyscope ds ii, but due to the procedural problems that were performed (endoscopic sphincterotomy, endoscopic papillary balloon dilatation and endoscopic papillary large balloon dilation) to the patient.Reportedly, there was no problem with spybite max.There were no future procedures mentioned, and the procedure was completed using another of the same device.The patient's condition at the conclusion of the procedure was reported to be stable and is improving.

• 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: 18100167
• MDR Text Key: 327712364
• Report Number: 3005099803-2023-06114
• 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: 12/20/2023

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 Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0032203835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2023
• 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
• Patient Outcome(s): Required Intervention