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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC CORPORATION ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901050
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. (b)(4). 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.
 
Event Description
Note: this event pertains to one of four zero tip baskets unpacked for the same procedure. It was reported to boston scientific corporation that a zero tip basket was unpacked for a procedure on an unknown date. According to the complainant, prior to the procedure, two devices were unpacked, and the customer noticed that there was a black dye seeping through the devices packaging. Two more packages were discovered to have black dye seeping through the packages. The customer did not use any of the four devices in the procedure. The procedure was completed with a fifth zero tip basket. 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.
 
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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 Key9683077
MDR Text Key190154824
Report Number3005099803-2020-00289
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/21/2021
Device Model NumberM0063901050
Device Catalogue Number390-105
Device Lot Number0024814049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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