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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM REPERFUSION CATHETER; CATHETER, THROMBUS RETRIEVER

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IMPERATIVE CARE. INC ZOOM REPERFUSION CATHETER; CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number ICRC055137
Device Problems Material Separation (1562); Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2023
Event Type  Injury  
Event Description
During a stroke case, the treating physician used a zoom 88, zoom 55, zoom 35, and third party stent retriever.It was reported that after performing six passes, the distal segment of the zoom 55 was stretched and separated from the rest of the catheter but held together by the coil.The physician retrieved the entire zoom 55 catheter, including the separated portion.The patient was reported to be stable, and no patient sequelae were reported.Several attempts were made to have the treating physician provide further details of this event; however, they were unsuccessful.
 
Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.The manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.The exact root cause of the separation could not be determined as the device was not returned for investigation, and there was limited information and no case images provided.Based on the information provided, the physician performed six passes with the same zoom 55.Instruction for use states, "do not perform more than 3 clot retrieval attempts with the zoom catheter.".
 
Event Description
Refer to h11 for follow-up information.
 
Manufacturer Narrative
Additional information was provided by the treating physician on 01/29/2024: the occlusion was in the distal left m1 segment.In the first pass, access was obtained with a zoom 88 access catheter and a zoom 55 aspiration catheter.The patient reportedly had a type 3 arch.The physician required some effort to navigate zoom 88 to the left internal carotid artery (ica) cavernous successfully.A slight bend was observed on the zoom 88 and the tip of the catheter was suspected to be ovalized.Suction was applied to the zoom 55 as it advanced forward.While retracting the zoom 55, the physician reported minimal resistance from the middle cerebral artery to the lateral; however, there was significant resistance halfway upon removal.The zoom 55 was removed from the patient.The physician found that the distal portion of the zoom 55 was stretched and still attached to the proximal part by two to three loops of coil.For passes two through six, the zoom 88 was kept in place in the left ica cavernous.The zoom 55 was replaced with a third-party aspiration catheter and a stent retriever.Since the balloon angioplasty did not work because it was a "white clot", the stent retriever was replaced by a different stent retriever.The case was completed with a successful removal of the clot.The patient was reported to be doing well with good improvement and the patient achieved complete reperfusion with a tici 3 score.
 
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Brand Name
ZOOM REPERFUSION CATHETER
Type of Device
CATHETER, THROMBUS RETRIEVER
Manufacturer (Section D)
IMPERATIVE CARE. INC
1359 dell avenue
campbell CA 95008 6609
Manufacturer (Section G)
IMPERATIVE CARE, INC.
1359 dell avenue
campbell CA 95008 6609
Manufacturer Contact
joy patel
1359 dell
campbell, CA 95008-6609
MDR Report Key18585045
MDR Text Key333773244
Report Number3014590708-2024-00001
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00812212030474
UDI-Public00812212030474
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K210996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/15/2024
Device Model NumberICRC055137
Device Catalogue NumberICRC055137
Device Lot NumberF2322202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/25/2024
Supplement Dates Manufacturer Received01/29/2024
Supplement Dates FDA Received02/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EMBOTRAP; RED 62 ASPIRATION CATHETER; SOLITAIRE STENT RETRIEVER; ZOOM 35; ZOOM 88
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight118 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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