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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR VL; STENT, URETERAL
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BOSTON SCIENTIFIC CORPORATION CONTOUR VL; STENT, URETERAL Back to Search Results
Model Number M0061801560
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
(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 vl ureteral stent was used during an placement jj catheter procedure in the ureter, performed on (b)(6), 2020.According to the complainant, during unpacking, it was noticed that the sterile packaging was opened.It was reported that the procedure was successfully completed.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 good.
 
Manufacturer Narrative
Block e1: initial reporter state: (b)(6) block h6: devie code 1444 captures the reportable event of unsealed packaging.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the returned contour stent was analyzed and the stent looks in good condition.The device was received with its original pouch already opened, the pouch did not present any damage.The package shows evidence of seal process and the device was returned inside the original bag.No other issues with the device were noted.The reported event of sterility compromised was confirmed.Based on the investigation analysis, it is possible that the way in which the device was handled and manipulated may have contributed to the encountered pouch open.It is most likely that the adverse event occurred during the preparation for use and the device had no influence on event.The pouch has evidence that sealed was performed correctly during manufacturing process and the device does not present any damage.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.
 
Event Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during an placement jj catheter procedure in the ureter, performed on (b)(6), 2020.According to the complainant, during unpacking, it was noticed that the sterile packaging was opened.It was reported that the procedure was successfully completed.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 good.
 
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Brand Name
CONTOUR VL
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10190007
MDR Text Key197153435
Report Number3005099803-2020-02389
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729067986
UDI-Public08714729067986
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,foreig
Type of Report Initial,Followup
Report Date 08/05/2020
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 Date02/12/2023
Device Model NumberM0061801560
Device Catalogue Number180-156
Device Lot Number0025205086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Initial Date Manufacturer Received 05/29/2020
Initial Date FDA Received06/24/2020
Supplement Dates Manufacturer Received07/21/2020
Supplement Dates FDA Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age40 YR
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