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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER
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BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER Back to Search Results
Model Number M00546780
Device Problems Connection Problem (2900); Device-Device Incompatibility (2919); Optical Problem (3001); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2020
Event Type  malfunction  
Manufacturer Narrative
(pro code): ntn.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 second of two spyglass discover digital catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a stone extraction procedure in the gallbladder performed on (b)(6) 2020.According to the complainant, during the procedure, the image of the spyglass discover catheter was lost and could not start the case.A second spy discover catheter was used; however, the image was also lost approximately 30 minutes into the procedure during stone removal.Reportedly, during set up, both catheters would not connect correctly.Reportedly, the connection ports were not clicking in correctly.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Event Description
Note: this report pertains to the second of two spyglass discover digital catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a stone extraction procedure in the gallbladder performed on (b)(6), 2020.According to the complainant, during the procedure, the image of the spyglass discover catheter was lost and could not start the case.A second spy discover catheter was used; however, the image was also lost approximately 30 minutes into the procedure during stone removal.Reportedly, during set up, both catheters would not connect correctly.Reportedly, the connection ports were not clicking in correctly.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block d2 (pro code): ntn block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyglass discover digital catheter was analyzed, and a visual evaluation was performed.The catheter did not have any forceps marks on the shaft of the catheter.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.It was noted that the tip was damaged.It is likely that this was caused by laser usage in close proximity to the cap, resulting in the cap melting as it was exposed to heat.An image assessment was performed.Upon plugging the device into the controller, it displayed a live, clear image.No issues were identified with the image.No issues were 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 issues were identified with the image.Real-time x-ray was used to image the distal tip, including the thru-silicon vias (tsvs), redistribution layer (rdl), and camera wires.No damage was observed to the camera wires at or inside of the camera housing/cap.In the handle, no damage was observed to the printed circuit board assembly (pcba).The handle was opened and the components within were visually inspected.It was noted that significant fluid residue was present on the pcba.The residue appeared to be crystalline in nature, indicating it may be procedural fluids.The exact composition of the residue was unable to be determined.It is likely that the fluid made contact with board mounted components, resulting in electrical paths between components that shorted the signal and resulted in a loss of image during the procedure.The reported event wa confirmed.It is possible that the design of the device does not adequately protect against fluid in the handle.An investigation to address this issue is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
Manufacturer Narrative
Block d2 (pro code): ntn block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyglass discover digital catheter was analyzed, and a visual evaluation was performed.The catheter did not have any forceps marks on the shaft of the catheter.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.It was noted that the tip was damaged.It is likely that this was caused by laser usage in close proximity to the cap, resulting in the cap melting as it was exposed to heat.An image assessment was performed.Upon plugging the device into the controller, it displayed a live, clear image.No issues were identified with the image.No issues were 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 issues were identified with the image.Real-time x-ray was used to image the distal tip, including the thru-silicon vias (tsvs), redistribution layer (rdl), and camera wires.No damage was observed to the camera wires at or inside of the camera housing/cap.In the handle, no damage was observed to the printed circuit board assembly (pcba).The handle was opened and the components within were visually inspected.It was noted that significant fluid residue was present on the pcba.The residue appeared to be crystalline in nature, indicating it may be procedural fluids.The exact composition of the residue was unable to be determined.It is likely that the fluid made contact with board mounted components, resulting in electrical paths between components that shorted the signal and resulted in a loss of image during the procedure.The reported event wa confirmed.It is possible that the design of the device does not adequately protect against fluid in the handle.An investigation to address this issue is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Block h11: correction: block g5 (premarket / 510(k) #) has been corrected.
 
Event Description
Note: this report pertains to the second of two spyglass discover digital catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a stone extraction procedure in the gallbladder performed on (b)(6), 2020.According to the complainant, during the procedure, the image of the spyglass discover catheter was lost and could not start the case.A second spy discover catheter was used; however, the image was also lost approximately 30 minutes into the procedure during stone removal.Reportedly, during set up, both catheters would not connect correctly.Reportedly, the connection ports were not clicking in correctly.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
SPYGLASS DISCOVER DIGITAL CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10513404
MDR Text Key206548077
Report Number3005099803-2020-03851
Device Sequence Number1
Product Code FBN
UDI-Device Identifier08714729994183
UDI-Public08714729994183
Combination Product (y/n)N
PMA/PMN Number
K200483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/04/2021
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 Date06/16/2022
Device Model NumberM00546780
Device Catalogue Number4678
Device Lot Number0025603009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Initial Date Manufacturer Received 08/20/2020
Initial Date FDA Received09/10/2020
Supplement Dates Manufacturer Received10/09/2020
01/04/2021
Supplement Dates FDA Received11/05/2020
01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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