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 ANGIOJET SPIROFLEX THROMBECTOMY SET; THROMBECTOMY CATHETER
  • 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 ANGIOJET SPIROFLEX THROMBECTOMY SET; THROMBECTOMY CATHETER Back to Search Results
Model Number 106553-001
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2015
Event Type  malfunction  
Event Description
The customer reported the following: during a thrombectomy procedure in which an angiojet spiroflex catheter was utilized, the catheter cracked mid-device.The physician removed the catheter and used a second angiojet catheter to successfully complete the procedure.No adverse event was reported.
 
Manufacturer Narrative
Quality assurance product analysis reviewed the info that was provided by the site.The angiojet spiroflex catheter that was in use during the event is being returned to (b)(4) for a full eval.Once the eval is completed, a follow up report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANGIOJET SPIROFLEX THROMBECTOMY SET
Type of Device
THROMBECTOMY CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC
minneapolis MN
Manufacturer Contact
diane exkert
9055 evergreen blvd., n.w.
minneapolis, MN 55433
7249408677
MDR Report Key4756912
MDR Text Key5888748
Report Number2183460-2015-00033
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/13/2015
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 Model Number106553-001
Device Catalogue NumberANGIOJET
Device Lot Number159628
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/13/2015
Initial Date FDA Received05/05/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-