Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ASCERTA?; STENT, URETERAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - COSTA RICA (COYOL) ASCERTA?; STENT, URETERAL Back to Search Results
Model Number M0061456150
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 03/10/2015
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an ascerta¿ ureteral stent device package was noted to have a compromised seal prior to a stent exchange on (b)(6) 2015.According to the complainant, while removing the device from the box, it was noted that the sterile packaging was loose, and the seal was noted to be compromised.No damage was observed on the outside packaging and the box.The device was not used on a patient.The procedure was completed with another ascerta¿ ureteral stent device.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 fine.
 
Manufacturer Narrative
Analysis of the returned ascerta¿ ureteral stent pouch revealed that it was opened when received.There was an evidence that seal process was performed properly.Therefore, taking into consideration these factors and the analysis performed in the device packaging, the most probable root cause is ¿handling damage¿.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that an ascerta¿ ureteral stent device package was noted to have a compromised seal prior to a stent exchange on (b)(6) 2015.According to the complainant, while removing the device from the box, it was noted that the sterile packaging was loose, and the seal was noted to be compromised.No damage was observed on the outside packaging and the box.The device was not used on a patient.The procedure was completed with another ascerta¿ ureteral stent device.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 fine.
 
Manufacturer Narrative
Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASCERTA?
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4659422
MDR Text Key5854822
Report Number3005099803-2015-00885
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974541
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,Followup
Report Date 03/11/2015
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 Nurse
Device Expiration Date09/26/2015
Device Model NumberM0061456150
Device Catalogue Number145-615
Device Lot Number0016396540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/23/2015
Initial Date FDA Received04/03/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-