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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 Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 a procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noticed that the working channel sleeve of the spyscope ds was protruded.There were no reported accessory device inside the spyscope ds when the working channel sleeve protruded.The procedure was completed with this device.There were no reported patient complications as a result of this event.
 
Manufacturer Narrative
(b)(4).Block h10: a visual assessment was performed after disinfection.As received, the working channel sleeve (wcs) protruded.Maximum wcs protrusion was observed when the distal tip was articulated by turning the large knob in both 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, appeared to show evidence of adhesion.The complaint was consistent with the reported complaint incident 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 post (b)(6) 2018 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 manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in a procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noticed that the working channel sleeve of the spyscope ds was protruded.There were no reported accessory device inside the spyscope ds when the working channel sleeve protruded.The procedure was completed with this device.There were no reported patient complications as a result of this event.
 
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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 Key8313007
MDR Text Key135349067
Report Number3005099803-2019-00474
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 03/28/2019
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 Model NumberM00546600
Device Catalogue Number4660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/06/2019
Supplement Dates Manufacturer Received03/06/2019
Supplement Dates FDA Received03/28/2019
Patient Sequence Number1
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