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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL
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BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL Back to Search Results
Model Number M0061802230
Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a contour ureteral stent was used to treat stones during a ureteral lithotripsy procedure in the ureter performed on (b)(6) 2023.During the procedure, they could not implant the stent after several attempts.It was found that the stent had a crack and was folded.The procedure was successfully completed with another contour ureteral stent.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.A photo of the complaint device was provided and showed that the stent was torn.
 
Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn material, inside the patient.
 
Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn material, inside the patient.Block h10: the returned contour ureteral stent was analyzed, and a media and visual evaluation noted that the bladder coil was buckled and torn.A functional evaluation noted that a mandrel 0.039 was loaded into the device and no resistance was felt, however the returned device shows evidence of the difficult to advance reported.No other problems with the device were noted.The reported event of stent torn material and stent difficult to advance was confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get torn during procedure affecting the performance of the device.For the problem of stent coil buckled/accordion and stent difficult to advance, it is possible to conclude that these problems are related and could be caused by operational factors, such as interaction of the device between the positioner and the guide wire.It's possible to conclude that due to the buckled founded in the device coil, this could have been generated because the physician could have difficulties placing the device in the target, leading the physician to use an excess of force in the placement of the device leading the device to be buckled.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
 
Event Description
It was reported to boston scientific corporation that a contour ureteral stent was used to treat stones during a ureteral lithotripsy procedure in the ureter performed on (b)(6) 2023.During the procedure, they could not implant the stent after several attempts.It was found that the stent had a crack and was folded.The procedure was successfully completed with another contour ureteral stent.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.A photo of the complaint device was provided and showed that the stent was torn.
 
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Brand Name
CONTOUR
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18524346
MDR Text Key332977119
Report Number2124215-2023-75511
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K974541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/23/2024
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 NumberM0061802230
Device Catalogue Number180-223
Device Lot Number0031335503
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2023
Initial Date FDA Received01/17/2024
Supplement Dates Manufacturer Received02/02/2024
Supplement Dates FDA Received02/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient SexMale
Patient Weight62 KG
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