MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER

Model Number M00546780

Device Problems 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

(product code): ntn.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(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 spyglass discover digital catheter was used in the common bile duct during a percutaneous transhepatic cholangiography (ptc) procedure performed on (b)(6) 2021.During the procedure, the scope did not connect to the controller properly.The image was lost approximately one hour during the procedure.The spyscope was unplugged and plugged back into the controller; eventually, they could not get the image to display.The procedure was rescheduled and was completed with a spyscope ds.There were no patient complications reported as result of this event.

Event Description

It was reported to boston scientific corporation that a spyglass discover digital catheter was used in the common bile duct during a percutaneous transhepatic cholangiography (ptc) procedure performed on (b)(6) 2021.During the procedure, the scope did not connect to the controller properly.The image was lost approximately one hour during the procedure.The spyscope was unplugged and plugged back into the controller; eventually, they could not get the image to display.The procedure was rescheduled on (b)(6) 2021 or (b)(6) 2021 and was completed with a spyscope ds.There were no patient complications reported as result of this event.

Manufacturer Narrative

Block d2b (product code): ntn.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Block h6 (impact codes): impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spy discover catheter was analyzed, and a visual evaluation noted that no forceps 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 via (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.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.

• Brand Name: SPYGLASS DISCOVER DIGITAL CATHETER
• 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: 13094209
• MDR Text Key: 282823711
• Report Number: 3005099803-2021-07963
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• 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 Model Number: M00546780
• Device Catalogue Number: 4678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• 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
• 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