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 24700
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/05/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified left forearm vein.A non bsc 6f sheath was inserted from the elbow vein and a non bsc guidewire was passed through.Then, a 7.0mmx40mmx40cm (4f) sterling balloon catheter was advanced for pre-dilation.However, during first inflation at 10 atmospheres for 10 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient serious injury or adverse event 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 Key8176851
Report Number2134265-2018-64118
Device Sequence Number16688927
Product Code DQY
UDI-Device Identifier08714729124092
UDI-Public08714729124092
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K053116
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/18/2018
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 Date09/19/2021
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0022680621
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2018
Initial Report FDA Received Date12/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-