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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 Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2018
Event Type  Injury  
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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during a procedure for choledocholithiasis performed on (b)(6) 2018.According to the complainant, during the procedure, the spyscope ds was inserted to take a biopsy since the patient had a suspected tumor in the cbd.After taking the biopsy, the physician found a stone located in the cbd.The physician then decided to use an autolith electrohydraulic lithotripsy (ehl) probe to break the stone.After firing the ehl probe a few times, the stone was destroyed.During fluoroscopy, the physician saw a little piece of metal inside the common bile duct and confirmed that the piece of metal looked like the working channel sleeve of the spyscope ds.The stone and piece of working channel sleeve were removed using a trapezoid basket.The procedure was completed with the original spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6 (device codes): the problem code 2907 captures the reportable event of device component detached.The problem code 2979 captures the reportable event of working channel sleeve protrusion.Block h10: 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 knobs in all directions.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The wcs was removed.Witness marks were noted on the pebax.The white and clear areas along bond a, appeared to show evidence of adhesion.In addition, there was no component of the device detached.The complaint was consistent with the reported event of working channel sleeve protruding but the complaint detached tip component was not confirmed.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 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.Block h11: correction to block h6 (device codes).
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during a procedure for choledocholithiasis performed on (b)(6) 2018.According to the complainant, during the procedure, the spyscope ds was inserted to take a biopsy since the patient had a suspected tumor in the cbd.After taking the biopsy, the physician found a stone located in the cbd.The physician then decided to use an autolith electrohydraulic lithotripsy (ehl) probe to break the stone.After firing the ehl probe a few times, the stone was destroyed.During fluoroscopy, the physician saw a little piece of metal inside the common bile duct and confirmed that the piece of metal looked like the working channel sleeve of the spyscope ds.The stone and piece of working channel sleeve were removed using a trapezoid basket.The procedure was completed with the original spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.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 Key8197886
MDR Text Key131471117
Report Number3005099803-2018-62258
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 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2020
Device Model NumberM00546600
Device Catalogue Number4660
Device Lot Number0021936395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Initial Date Manufacturer Received 12/03/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received01/24/2019
Supplement Dates FDA Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient Weight63
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