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

Model Number M00546610

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

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

(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 common bile duct and common hepatic duct during a cholangioscopy procedure performed on (b)(6) 2021.During the biopsy procedure, there was no visualization on the spyscope ds ii catheter.They reconnected the spyscope and without result.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the common bile duct and common hepatic duct during a cholangioscopy procedure performed on (b)(6) 2021.During the biopsy procedure, there was no visualization on the spyscope ds ii catheter.They reconnected the spyscope and without result.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): 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 no 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 problems were identified with the image.No problems were observed with physical connectivity of the device.The umbilicus connector was visually inspected and no damage or defects were noted.The lighting controls on the controller were tested and the scope lighting adjusted accordingly, no problems were observed with scope lighting or plastic optical fibers (pofs).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 connection of the camera wires to the pcba was inspected.No damage or defect was noted on the bond between the solder pads and the camera wires.The glue feature was wiggled with tweezers to test the solder bond of the wires, and no change to the image was noted.Pressure was applied to the ground pad on the pcba using a screwdriver, and no flex was observed on the pcba.It appeared fully bonded to the breakout and no components on the board appeared damaged.The camera wire in the breakout region was visually inspected.No damage was noted to the camera wire or jacket.Signs of procedural residue were present inside the handle, indicating 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.No change to the image was observed during this testing.The reported event was not confirmed.Product analysis was unable to replicate reported visualization problems.A review of the risk documentation confirms that the failure is not a new or unanticipated event.The risk documentation lists that the reported event can be caused by damage to the electronic components, fluid leaks, tip damage, or cross-talk between electronics.The design failure modes and effects analysis (dfmea) lists mitigations in place that control design features through specification and manufacturing inspection, and therefore it is unlikely a problem with the design of the device.A device history record (dhr) confirms the device met all manufacturing specifications, and therefore there is unlikely a problem related to manufacturing.Based on all gathered information, the investigation concluded that the most probable root cause of this complaint is no problem detected.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.Block h11: correction - block h6 (impact code and device code) has been corrected.

• 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: 13095320
• MDR Text Key: 282826887
• Report Number: 3005099803-2021-07977
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

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: 09/01/2023
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0027947689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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