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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; 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 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 bile duct during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the working channel sleeve of the spyscope protruded.Reportedly, no part of the spyscope ds device was detached.The procedure was still completed with this device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the working channel sleeve of the spyscope protruded.Reportedly, no part of the spyscope ds device was detached.The procedure was still completed with this device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
A visual assessment was performed after disinfection.The catheter was kinked in several locations, beginning near the distal end.As received, the working channel sleeve protruded.The tips of the protruding sleeve were frayed.A functional assessment was performed and maximum protrusion was observed when the distal tip was articulated by turning the large knob in the clockwise direction.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 areas along bond a appear to show evidence of adhesion.The complaint was consistent with the reported event of working channel sleeve protruding.Based on the 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]. therefore, the complaint investigation conclusion code selected for the working channel sleeve protrusion issue is manufacturing process design.An investigation is underway to address this issue.A dhr (device history record) review was performed and no deviation was found.
 
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Brand Name
SPYSCOPE DS ACCESS & DELIVERY CATHETER
Type of Device
CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
MDR Report Key7669615
MDR Text Key113642518
Report Number3005099803-2018-02262
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 06/12/2018
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 Date03/27/2020
Device Model NumberM00546600
Device Catalogue Number4660
Device Lot Number21925327
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Initial Date Manufacturer Received 06/12/2018
Initial Date FDA Received07/09/2018
Supplement Dates Manufacturer Received07/10/2018
Supplement Dates FDA Received07/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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