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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 Problems Break (1069); Deformation Due to Compressive Stress (2889)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
(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 zero tip basket stone retrieval basket was to be used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019. According to the complainant, when the zero tip basket was inspected prior to the procedure, after opening and closing the basket once as a test, the sheath was found buckled and broken at the distal end. As a result, the basket failed to closed. Another zero tip basket was used to complete the procedure. No patient complications were reported as a result of this event. The patient's condition at the conclusion of the procedure is reported to be good.
 
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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 Key9224128
MDR Text Key178741973
Report Number3005099803-2019-05163
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeKS
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,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2021
Device Model NumberM0063901050
Device Catalogue Number390-105
Device Lot Number0023959349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2019
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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