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 OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR
  • 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 OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 44021
Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2019
Event Type  malfunction  
Event Description
It was reported that catheter entanglement on the guidewire occurred.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.After passing through the guidewire, the device was delivered.There was resistance noted when crossing the lesion.When the imaging was performed it was observed under fluoroscopy that there was entanglement between the guidewire and this ivus device.The guidewire was carefully removed and the procedure was continued re-using it again.There were no patient complications that were reported.
 
Event Description
It was reported that catheter entanglement on the guidewire occurred.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.After passing through the guidewire, the device was delivered.There was resistance noted when crossing the lesion.When the imaging was performed it was observed under fluoroscopy that there was entanglement between the guidewire and this ivus device.The guidewire was carefully removed and the procedure was continued re-using it again.There were no patient complications that were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the catheter was received without the distal tip assembly.Device analysis revealed multiple kinks in the sheath assembly in the distal end.The guidewire test can't be performed snince the distal tip was not received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTICROSS 18
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8811936
MDR Text Key151737320
Report Number2134265-2019-08542
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/14/2021
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0023649328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2019
Date Manufacturer Received08/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-