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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M00546600
Device Problems Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/20/2018
Event Type  malfunction  
Manufacturer Narrative
(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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the ductus choledochus during a cholangioscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician noticed that the working channel sleeve of the spyscope ds protruded while performing electrohydraulic lithotripsy (ehl).There were no reported issues with the accessory device.The procedure was still completed with this device.The patient had bleeding in the duct which was stopped with adrenaline injection.In the physician's assessment, it is unknown if the bleeding was due to the spyscope ds or was related to stone retrieval.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
(device codes): the problem code 2979 captures the reportable event of working channel sleeve protrusion.A visual assessment was performed.As received, the working channel sleeve protruded.Maximum working channel sleeve protrusion was observed when the distal tip was articulated by turning the knobs in all directions.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The working channel sleeve was removed.Witness marks were noted on the pebax.The white and clear areas along bond a, as well as the proximal strands of the working channel sleeve braid remaining attached to the pebax, appear to show evidence of adhesion.The complaint was consistent with the reported event of working channel sleeve protruding.Based on investigation results, the underlying cause of working channel sleeve protrusion is an insufficient bond, particularly the second heat cycle of the working channel sleeve bonding process [bond b].Working channel sleeve protrusion in devices manufactured with post 01mar2018 changes has been determined to be a design issue, therefore, the complaint investigation conclusion code selected for the working channel sleeve protrusion issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation is underway to address this issue.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the ductus choledochus during a cholangioscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician noticed that the working channel sleeve of the spyscope ds protruded while performing electrohydraulic lithotripsy (ehl).There were no reported issues with the accessory device.The procedure was still completed with this device.The patient had bleeding in the duct which was stopped with adrenaline injection.In the physician's assessment, it is unknown if the bleeding was due to the spyscope ds or was related to stone retrieval.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
SPYSCOPE DS
Type of Device
CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8152816
MDR Text Key130049505
Report Number3005099803-2018-61889
Device Sequence Number1
Product Code FBN
UDI-Device Identifier08714729863236
UDI-Public08714729863236
Combination Product (y/n)N
PMA/PMN Number
K142922
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/20/2019
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 Date10/17/2020
Device Model NumberM00546600
Device Catalogue Number4660
Device Lot Number0022813595
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Initial Date Manufacturer Received 11/20/2018
Initial Date FDA Received12/11/2018
Supplement Dates Manufacturer Received01/28/2019
Supplement Dates FDA Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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