Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M00546600
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)
Event Date 01/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician noticed that the working channel sleeve was protruding from the tip of the spyscope ds.A second spyscopeds was used, the working channel sleeve protruded, scratched the bile duct, and bleeding was noticed.Per the complainant there was no medical treatment required to address the bleed.The procedure was completed with the second spyscope digital access and delivery catheter.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6 (device codes): 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 remained consistent 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.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 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 bile duct during a cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician noticed that the working channel sleeve was protruding from the tip of the spyscope ds.A second spyscopeds was used, the working channel sleeve protruded, scratched the bile duct, and bleeding was noticed.Per the complainant there was no medical treatment required to address the bleed.The procedure was completed with the second spyscope digital access and delivery catheter.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8363832
MDR Text Key137002180
Report Number3005099803-2019-00894
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 Expiration Date08/28/2020
Device Model NumberM00546600
Device Catalogue Number4660
Device Lot Number0022583096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Initial Date Manufacturer Received 01/28/2019
Initial Date FDA Received02/22/2019
Supplement Dates Manufacturer Received03/06/2019
Supplement Dates FDA Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-