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 SPIROFLEX; 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 SPIROFLEX; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 10706
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2020
Event Type  malfunction  
Event Description
It was reported that catheter break occurred.The target lesion was located in the coronary artery.An angiojet spiroflex catheter was selected for a thrombectomy procedure.However, it was noted that the catheter would not prime.Another angiojet spiroflex catheter was advanced and completed the procedure; however, during withdrawal, the catheter was broken.The device was completely removed from the patient's body.No patient complications were reported and patient was fine.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a spiroflex thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected.Blood was inside the device and the waste bag was cut-off, when received.The waste bag was not returned for analysis.Inspection of the device revealed that the shaft was kinked 47cm distal of the strain relief with a hole in the shaft at the same location.
 
Event Description
It was reported that catheter break occurred.The target lesion was located in the coronary artery.An angiojet spiroflex catheter was selected for a thrombectomy procedure.However, it was noted that the catheter would not prime.Another angiojet spiroflex catheter was advanced and completed the procedure; however, during withdrawal, the catheter was broken.The device was completely removed from the patient's body.No patient complications were reported and patient was fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANGIOJET SPIROFLEX
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9695608
MDR Text Key179505449
Report Number2134265-2020-01136
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729889380
UDI-Public08714729889380
Combination Product (y/n)N
PMA/PMN Number
K072769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/10/2020
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 Date10/27/2020
Device Model Number10706
Device Catalogue Number10706
Device Lot Number0023119943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Initial Date Manufacturer Received 01/23/2020
Initial Date FDA Received02/11/2020
Supplement Dates Manufacturer Received02/11/2020
Supplement Dates FDA Received03/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-