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 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
  • 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 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24630
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2020
Event Type  malfunction  
Event Description
It was reported that balloon had micro perforation.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, upon inflation it was noted that the device had micro perforations so the balloon slowly deflated.The procedure was able to perform using the said device through vigorous inflation and completed by a plain balloon post dilation.No patient complications were reported.
 
Event Description
It was reported that balloon had micro perforation.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, upon inflation it was noted that the device had micro perforations so the balloon slowly deflated.The procedure was able to perform using the said device through vigorous inflation and completed by a plain balloon post dilation.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified in the balloon which is indicative of a leak.No tears or holes were visible in the balloon.The device was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified in the mid-section of the balloon.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon with no issues identified.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no issues with the hypotube.No other issues were identified during the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9700226
MDR Text Key179753039
Report Number2134265-2020-01335
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/01/2020
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
Device Operator Health Professional
Device Expiration Date05/06/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0023750789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Initial Date Manufacturer Received 02/05/2020
Initial Date FDA Received02/12/2020
Supplement Dates Manufacturer Received03/27/2020
Supplement Dates FDA Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-