• 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) ZERO TIP¿ DISLODGER, STONE, BASKET, URETERAL, METAL

  • 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) ZERO TIP¿ DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901030
Device Problem Difficult to Open or Close (2921)
Patient Problem Perforation (2001)
Event Date 06/27/2017
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. However, the complainant stated that the device was used prior to the expiration date. The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was used in the kidney during a flexible ureteroscopy procedure performed on (b)(6) 2017. According to the complainant, during the procedure, the basket failed to release the stone and was stuck inside the patient. The wire from the handle was cut but still failed to release the stone. The stone was finally removed from the patient by pulling the basket. However, doing so ripped the ureter. The physician repaired the ureter with stitches. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZERO TIP¿
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
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 Key6825262
MDR Text Key83833428
Report Number3005099803-2017-02515
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901030
Device Catalogue Number390-103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/28/2017 Patient Sequence Number: 1
-
-