• 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 CORPORATION 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 CORPORATION ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901050
Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. Device code 3191 is being used to capture the reportable issue of procedure aborted/cancelled. Patient code 3165 captures the reportable event of unretrieved device fragment. Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned. The complainant indicated that the device was 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 basket was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, a piece of the basket made contact with a laser and resulted in a piece of the basket wire detaching in the patient. The physician was unable to find the missing part. It was noted that the procedure was unsuccessful, and the stone was only able to be partially removed. No patient complications were 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.
 
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 CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key10705175
MDR Text Key212103076
Report Number3005099803-2020-04645
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeNL
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 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901050
Device Catalogue Number390-105
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 Received09/23/2020
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: 10/20/2020 Patient Sequence Number: 1
-
-