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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
Model Number M00546610
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Event Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01247 for the first trapezoid basket, 3005099803-2024-01248 for the second trapezoid basket, and 3005099803-2024-01269 for the spyscope it was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) cholangioscopy procedure performed for complex stone removal in the bile duct on (b)(6) 2024.During the procedure, the spyscope appeared to be working but the autolith touch ehl probe would not advance through the scope.After two attempts, a third ehl probe was positioned but would not fire.The machine was on, but a current wasnt delivered.The physician then reached for a trapezoid basket which split down the middle.A second basket was introduced, and it split as well.The procedure was not completed due to this event.Upon further inspection after the procedure was cancelled, it was determined that the ehl machine was functioning as intended and the ehl probes likely experienced resistance due to angulation at the elevator.Close observation of the probes showed kinks that were incurred during the advancement of the probes.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
 
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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 Key18980358
MDR Text Key338622408
Report Number3005099803-2024-01269
Device Sequence Number1
Product Code FBN
UDI-Device Identifier08714729965404
UDI-Public08714729965404
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/26/2024
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
Device Model NumberM00546610
Device Catalogue Number4661
Device Lot Number0033409165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2024
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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