• 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 UNK-P-ZERO_TIP_BASKETS
Device Problem Break (1069)
Patient Problems Pain (1994); Injury (2348); Hematuria (2558)
Event Date 10/27/2016
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. (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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a zero tip nitinol basket was used during a lithotripsy procedure for treatment of kidney stones performed on or about (b)(6) 2016. According to the complainant, post-procedure, the patient suffered from continuing pain and blood in his urine. The patient was advised by his operating physician that these conditions were normal and were to be expected as a result of the procedure. The patient went to visit his primary care physician, who advised that it was not normal to still have blood present in the urine. Imaging studies were taken, and revealed that an approximately 11cm portion of the zero tip basket and wire had been left inside of the patient from the lithotripsy procedure performed on or about (b)(6) 2016. It was reported that the patient underwent several unsuccessful attempts to remove the basket and wire, but was ultimately removed from the patient successfully. All other information is unknown. Should additional relevant details become available; a supplemental report will be submitted.
 
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 Key7949761
MDR Text Key123193689
Report Number3005099803-2018-60715
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK-P-ZERO_TIP_BASKETS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated by Manufacturer? Yes
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: 10/09/2018 Patient Sequence Number: 1
-
-