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 ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY
  • 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 ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45027
Device Problems Break (1069); Difficult to Remove (1528); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event - 18 years of age or older.
 
Event Description
It was reported the catheter broke.The physician was treating the patient for a left lower extremity deep vein thrombosis (dvt).An 8french, 11cm sheath was placed in the left popliteal, two days prior to the interventional procedure.A catheter was advanced and used for an overnight lytic drip.During the interventional procedure, the physician used an angiojet zelante catheter for a total of 4 minutes in thrombectomy mode, as well as, power pulsed tpa into the inferior vena cava and common & external iliacs.When the procedure was being completed and the zelante catheter was being attempted to be removed from the 8f sheath, it got stuck.The physician tried to pull the catheter and in doing so, broke the catheter with a portion of it remaining inside the sheath.Both the sheath and catheter were removed from the patient together to complete the procedure.It was noted that the sheath and catheter were viualy inspected after being removed from the patient.It appeared as though the sheath had kinked at the hub and possibly had been damaged from overuse.This did not result in any patient complications.
 
Manufacturer Narrative
Age at time of event: 18 years of age or older.
 
Event Description
It was reported the catheter broke.The physician was treating the patient for a left lower extremity deep vein thrombosis (dvt).An 8french, 11cm sheath was placed in the left popliteal, two days prior to the interventional procedure.A catheter was advanced and used for an overnight lytic drip.During the interventional procedure, the physician used an angiojet zelante catheter for a total of 4 minutes in thrombectomy mode, as well as, power pulsed tpa into the inferior vena cava and common & external iliacs.When the procedure was being completed and the zelante catheter was being attempted to be removed from the 8f sheath, it got stuck.The physician tried to pull the catheter and in doing so, broke the catheter with a portion of it remaining inside the sheath.Both the sheath and catheter were removed from the patient together to complete the procedure.It was noted that the sheath and catheter were viualy inspected after being removed from the patient.It appeared as though the sheath had kinked at the hub and possibly had been damaged from overuse.This did not result in any patient complications.The returned product consisted of the zelantedvt thrombectomy system with an 8f introducer sheath.The effluent/supply line, shaft and tip were microscopically and visually inspected.Blood was present outside and inside of the device and 300ml of blood in the attached waste bag, when received.Inspection of the device revealed that distal shaft was detached at the location where the proximal and distal shaft are connected (96cm distal of the strain relief).The separated ends were jagged and damaged.There were numerous kinks throughout the shaft and hypotube of the device.The distal portion of the zelante catheter was received inside the returned introducer sheath.The shaft of the returned introducer sheath was buckled at the strain relief and had numerous kinks.The shaft of the zelante catheter was able to be removed from the introducer sheath with resistance due to the damaged sheath.The hypotube was detached at the jet body and was pulled proximally towards the separation.The shaft was damaged at the area of the separated hypotube with cut/scratches.The proximal saddle was detached from the hypotube and moved proximally towards the separation.The shaft was buckled between the proximal and distal markerbands.Review of the product specification indicates the zelantedvt is compatible with an 8f sheath.The returned sheath was an 8f sheath; therefore, there is no indication of a compatibility issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANGIOJET ZELANTEDVT
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8037890
MDR Text Key126170740
Report Number2134265-2018-62554
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
K151313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/21/2018
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
Device Operator Health Professional
Device Model Number45027
Device Catalogue Number45027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2018
Initial Date Manufacturer Received 10/12/2018
Initial Date FDA Received11/05/2018
Supplement Dates Manufacturer Received11/16/2018
Supplement Dates FDA Received11/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8FR X 11CM MEDTRONIC SHEATH; 8FR X 11CM MEDTRONIC SHEATH; 8FR X 11CM MEDTRONIC SHEATH
-
-