Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 STERLING; CATHETER, PERCUTANEOUS
  • 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 STERLING; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24690
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a moderately tortuous and moderately calcified renal artery.A 4.0mm x 15mm x 135cm sterling balloon catheter was advanced for dilatation.However, during the first inflation at 14 atmospheres, the balloon ruptured.The procedure was completed with the original device.No patient complications nor injuries were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STERLING
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12419356
Report Number2134265-2021-11235
Device Sequence Number3382958
Product Code LIT
UDI-Device Identifier08714729859260
UDI-Public08714729859260
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K141150
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/30/2021
Device Model Number24690
Device Catalogue Number24690
Device Lot Number0025295945
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/26/2021
Initial Report FDA Received Date09/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: PARENT 45
-
-