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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 Break (1069); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2023
Event Type  Injury  
Manufacturer Narrative
Distal and proximal segments of the zoom 55 catheter were returned for investigation.The investigation demonstrated severe damage to both the proximal and distal portions of the catheter shaft including stretching, kinking, and separation of the shaft material.The separated distal segment had kinks at each end of the segment and the distal tip was flattened.The proximal segment had a section of catheter fractured but was still attached to the rest of the segment via catheter jacket material.Additionally, the proximal segment had flattened sections on the catheter shaft.Investigation confirmed shaft breakage and suggested that an axial force was applied during the procedure, stretching the shaft materials prior to the device breaking.Based on the complaint information provided and device investigation the most likely root cause is retraction of the zoom 55 through tortuous anatomy with the presence of stenosis in the carotid.The manufacturing records for the zoom 55 were reviewed and demonstrated that the product met all the design and manufacturing specifications.
 
Event Description
A 61-year-old male was treated for acute ischemic stroke caused by an occlusion in the m1 segment of the middle cerebral artery.The patient was described as having a type 1-2 arch, supraclinoid ica stenosis and a large, dense/hard thrombus in the m1 segment.Access was obtained with a third-party access catheter and a zoom 55 aspiration catheter.The access catheter was positioned higher than the bifurcation in the distal cervical area on the initial ascent.No resistance was felt during advancement of the zoom 55, and the catheter went in smoothly to the stenosis.The physician attempted to push through the stenosis but was unsuccessful.The physician decided to perform a balloon angioplasty at the location of the stenosis.During the retraction of the zoom 55 after the balloon angioplasty, the physician noted that resistance was felt in the beginning, and it became increasingly difficult to retract the catheter.After retracting the zoom 55 catheter, the physician heard an audible snap and noticed that the distal part of the catheter remained stationary while moving the proximal part of the catheter.At this point, the physician did not observe the third-party access catheter moving within the anatomy.The subsequent angiogram showed the fragmented segment of the zoom 55 extended from the left m1 segment to just proximal of the cca bifurcation.The physician attempted to remove the fractured segment for 45 minutes using a variety of methods including stent retrievers, snares, a zoom 88, and a new zoom 55.However, these attempts were unsuccessful.A decision was made to transfer the patient to the or for a direct carotid cut-down procedure to remove the fragmented catheter.The entire fragmented segment of the zoom 55 was easily removed using a pair of tweezers.
 
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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 Key18089082
MDR Text Key327587967
Report Number3014590708-2023-00032
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
Report Date 11/07/2023
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 Date05/17/2024
Device Model NumberICRC055137
Device Catalogue NumberICRC055137
Device Lot NumberF2313202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/09/2023
Initial Date FDA Received11/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2023
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
EMBOTRAP STENT RETRIEVER; GATEWAY BALLOON; INFINITI ACCESS CATHETER; PHENOM 27 MICROCATHETER; SNARES; ZOOM 88
Patient Outcome(s) Required Intervention;
Patient Age61 YR
Patient SexMale
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