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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 10706
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
Event Type  malfunction  
Event Description
It was reported that catheter break occurred.An angiojet spiroflex was used for a thrombectomy procedure.However, it was noted that the device was cracked and started leaking and dripping.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet spiroflex catheter.The pump assembly, effluent/supply line, shaft, tip and spike line were visually examined for damage or any irregularities.The shaft showed 3 kinks.The kinks were located 34cm, 65.5cm, and 112.5cm from the tip.Functional testing was competed.The pump and device were inserted into the ultra drive unit console.The device was run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.Leaks were noticed from the kinked area of the device.No failures or error codes were noticed during the testing.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
 
Event Description
It was reported that catheter break occurred.An angiojet spiroflex was used for a thrombectomy procedure.However, it was noted that the device was cracked and started leaking and dripping.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
ANGIOJET SPIROFLEX
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11150539
MDR Text Key226262129
Report Number2134265-2021-00101
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 03/02/2021
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 Date07/07/2021
Device Model Number10706
Device Catalogue Number10706
Device Lot Number0024375791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Initial Date Manufacturer Received 12/31/2020
Initial Date FDA Received01/11/2021
Supplement Dates Manufacturer Received02/09/2021
Supplement Dates FDA Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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