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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 ICRC071137
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2023
Event Type  Injury  
Event Description
A patient presented with an occlusion at the right m1 segment of the middle cerebral artery.Access was obtained through the right radial artery using a guidewire and a zoom rdl.The patient's anterior genu of the internal carotid artery (ica) was reported to be very tight.The zoom rdl was placed at the anterior genu.For passes one and two, the zoom 71 was advanced through the zoom rdl to the clot location.The zoom rdl retracted back to the posterior genu when the physician was advancing the zoom 71 to the clot.The same zoom 71 and zoom rdl were used during the first two passes.When the physician attempted to remove the zoom 71 after the second pass, the zoom 71 was positioned in the distal ica before the ica terminus.Resistance was felt during retraction of the zoom 71 and the zoom 71 fractured at the distal portion of the catheter with the marker band still attached to the broken distal end.The exact length of the break was not provided.After the fracture, the tip of the zoom 71 was noted to be in the communicating segment of the ica.No kinks were observed on the zoom rdl.A v18 guidewire was used to pull the fractured zoom 71 segment into the zoom rdl.Under aspiration, the entire fractured segment of the zoom 71 and the zoom rdl were removed completely from the patient as a system.For passes three through six, the physician used a new zoom rdl, a new zoom 71, a third party microcatheter, and a stent retriever to complete the case.A tici 2b score was achieved, and the patient was reported in stable condition.No patient sequelae were reported.
 
Manufacturer Narrative
Imperative care inc.Has not yet received the device for evaluation.As the device has not been returned, the exact root cause of the separation could not be determined at this time.A supplemental report will be submitted, when the device is returned, and investigation is completed.The manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.
 
Event Description
Refer to h10 for follow-up information.
 
Manufacturer Narrative
Imperative care, inc.Received the proximal segment of the zoom 71 for investigation.Investigation confirmed shaft breakage and suggested that an axial force was applied to the zoom 71 during the procedure resulting in stretching of the shaft materials prior to the device breaking.Investigation demonstrated stretching and kinking of the proximal segment of the zoom 71.It was observed to have a section of stretched outer jacket with the coils pulled out.Based on the complaint information provided and device investigation the exact root cause for the zoom 71 shaft break could not be determined.Factors that were identified to contribute to the device complaint are the reported very tight anterior genu of the internal carotid artery (ica) and retraction of the zoom 71 against resistance.
 
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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 Key18187968
MDR Text Key328739132
Report Number3014590708-2023-00033
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00812212030450
UDI-Public00812212030450
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211476
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/05/2023
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? No
Device Operator Health Professional
Device Expiration Date06/06/2024
Device Model NumberICRC071137
Device Catalogue NumberICRC071137
Device Lot NumberF2313901
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2023
Initial Date FDA Received11/21/2023
Supplement Dates Manufacturer Received11/17/2023
Supplement Dates FDA Received12/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2023
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
SL-10 MICROCATHETER.; STENT RETRIEVERS.; V18 GUIDEWIRE.; ZOOM RDL.
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexFemale
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