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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 M006180223090
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
The event was reported by the distributor.The physician is: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 contour ureteral stent was used during a stent replacement procedure in the ureter, performed on (b)(6) 2021.During unpacking, it was noticed that the stent seemed to be separated.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a contour ureteral stent was used during a stent replacement procedure in the ureter, performed on (b)(6) 2021.During unpacking, it was noticed that the stent seemed to be separated.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
The event was reported by the distributor.The physician is: dr.(b)(6).Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned contour ureteral stent was analyzed, and a visual evaluation noted that the stent was found with the bladder pigtail detached (the detached section was missing).The suture string and the positioner did not returned for the analysis.No other issues with the device were noted.The reported event was not confirmed.According to product analysis, it was found with the bladder pigtail detached, this problem could have been generated due to the technique of the physician with an excess of force and the anatomy of the patient could contributed with the cause of the failure; also, it is important to mention that the detached section and the suture string did not returned that is aligned with the interaction of the device with the suture string, when it is pull out with an excess of force damaging the performance of the catheter.Since the adverse event occurred during the procedure and the device had no influence on event.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
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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
MDR Report Key12500826
MDR Text Key272643299
Report Number3005099803-2021-04888
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729424062
UDI-Public08714729424062
Combination Product (y/n)N
PMA/PMN Number
K974541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2024
Device Model NumberM006180223090
Device Catalogue Number180-223-09
Device Lot Number0027784616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Date Manufacturer Received09/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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