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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Manufacturer Narrative
Block d4, h4: the complainant was unable to report the upn and lot number; therefore the unique identifier (udi) #, manufacture date, and expiration date are unknown.Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
 
Event Description
It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during a procedure performed on (b)(6) 2024.During the procedure, the image of the spyscope ds ii did not appear on the screen.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
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Brand Name
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
Type of Device
CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key19011926
MDR Text Key339118671
Report Number3005099803-2024-01394
Device Sequence Number1
Product Code FBN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K183636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/01/2024
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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