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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M00546610
Device Problems Poor Quality Image (1408); Defective Device (2588); Device-Device Incompatibility (2919); Optical Problem (3001); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
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
Note: this report pertains to the first of two spyscope ds ii access and delivery catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used in the common bile duct (cbd) during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while they were in the common bile duct, the image of the spyscope ds ii flickered and disappeared during flushing.Reportedly, the visualization problem occurred approximately 30 minutes into the procedure.A second spyscope ds ii was used; however, the image also flickered and disappeared.Reportedly, water was coming in through the distal part of the two spyscope ds ii, and electrohydraulic lithotripsy (ehl) was performed when the visualization problems occurred.They attempted to reconnect the spyscope ds ii devices to the controller after the image was lost; however, the image was not restored.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 (device codes): problem code a27 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 was performed.The catheter demonstrated signs of use in the form of elevator marks along the shaft.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 problem identified with the image.No problem was 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 problem was identified with the image.X-ray imaging showed no problem to the distal tip, including the redistribution layer (rdl), thru-silicon vias (tsvs), or camera wires.X-ray imaging of the handle also showed no problem to the printed circuit board assembly (pcba) or camera wires.Irrigation was functionally tested by connecting a syringe filled with water to the irrigation tubing.Water was injected and flowed out the tip of the scope.No leaks were observed.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.It was noted that procedural residue was present in the breakout region at the end of the optics lumen.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 noted during this test.The reported event was not confirmed.Upon analysis, the returned device was unable to replicate or identify any problem that could have caused or contributed to the reported event.The device met all manufacturing specifications, and therefore there is unlikely a problem related to manufacturing.A review of the risk documentation confirms that the problem is not a new or unanticipated event, 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 complaints 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 the first of two spyscope ds ii access and delivery catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used in the common bile duct (cbd) during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while they were in the common bile duct, the image of the spyscope ds ii flickered and disappeared during flushing.Reportedly, the visualization problem occurred approximately 30 minutes into the procedure.A second spyscope ds ii was used; however, the image also flickered and disappeared.Reportedly, water was coming in through the distal part of the two spyscope ds ii, and electrohydraulic lithotripsy (ehl) was performed when the visualization problems occurred.They attempted to reconnect the spyscope ds ii devices to the controller after the image was lost; however, the image was not restored.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
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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
MDR Report Key11108913
MDR Text Key226074393
Report Number3005099803-2020-06494
Device Sequence Number1
Product Code FBN
UDI-Device Identifier08714729965404
UDI-Public08714729965404
Combination Product (y/n)N
PMA/PMN Number
K181439
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/04/2021
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 Date07/29/2022
Device Model NumberM00546610
Device Catalogue Number4661
Device Lot Number0025785179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received01/29/2021
Supplement Dates FDA Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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