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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA

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MICRO THERAPEUTICS, INC. DBA EV3 CATHERA Back to Search Results
Model Number FG19120-1030-1S
Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received a report that the phenom plus catheter experienced resistance in the distal part of the guide catheter and separated. The patient was undergoing onyx embolization treatment in the middle meningeal artery. The vessel tortuosity was moderate. The access vessel was the the femoral artery, which was 5mm in diameter. It was reported that the phenom plus catheter would not travel through the benchmark guide catheter, and the distal end of the phenom catheter ripped and became detached. The guide catheter appeared very flattened, which was thought to be the reason for the detachment. It was noted that the there was friction/difficulty during injection, and force had been applied during delivery/removal. The catheter tip was entrapped/stuck, and there was no vasospasm. No further medical or surgical intervention was required.  the patient did not experience any injury or complications. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a penumbra benchmark. 071 guide catheter and an apollo microcatheter.

 
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Brand NameCATHERA
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12294521
MDR Text Key267438913
Report Number2029214-2021-00990
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK151638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFG19120-1030-1S
Device Catalogue NumberFG19120-1030-1S
Device LOT Number221459990
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/05/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/07/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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