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

Model Number ICRC055137

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  Death  

Event Description

88-year-old female was undergoing a thrombectomy procedure to treat an occlusion at the left m2 segment.Access was obtained using a guidewire and a zoom 88 access catheter.The patient had a tortuous left common carotid with a big loop.The zoom 88 was advanced over the guidewire to the high cervical section of the internal carotid artery (ica) through a tight bend in the common carotid artery.The guidewire was removed and exchanged with a microwire.A zoom 55 was inserted into the zoom 88 over a third-party microcatheter and microwire.It was noted during insertion that the zoom 88 had a kink and tension/resistance was felt.The zoom 55, third party microcatheter, and a stent retriever were navigated to the clot over the microwire.The stent retriever was placed through the microcatheter, and the microcatheter was removed.After approximately a three-minute dwell time, the stent retriever was partially pulled into the zoom 55.While retracting the stent retriever and zoom 55 through the kinked zoom 88, the physician felt resistance and believes that this is where the distal end of the zoom 55 separated from the catheter.Imaging was completed and showed the distal end of the zoom 55 had separated and was in the ica terminus.Several unsuccessful attempts were made to remove the separated segment using different stent retrievers and multiple aspiration catheters.During one of these attempts, a similar issue occurred with a third-party aspiration catheter where that catheter became elongated, also likely due to the tortuous anatomy and kinked zoom 88.The physician determined that the separated segment of the zoom 55 was not flow limiting and decided not to remove it.Post procedure a decision was made per the patient's living will to place the patient on comfort care following the severe stroke.The patient passed away five days after the procedure.The physician attributed the death to the patient's family withdrawing care.

Manufacturer Narrative

The product has not yet been returned for further investigation.The manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.As the device has not been returned and with the limited case images provided, the exact root cause of the separation could not be determined.However, it is likely the tortuosity and insertion and retraction through a kinked catheter contributed to the zoom 55 separation.

• 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 avenue; campbell, CA 95008-6609
• MDR Report Key: 16921001
• MDR Text Key: 315116416
• Report Number: 3014590708-2023-00014
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2230101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GLIDEWIRE 0.038".; SOLITAIRE STENT RETRIVER.; SYNCHRO 0.014" MIRCOWIRE.; TREVO 3X32MM STENT RETRIEVER.; VELOCITY MICROCATHETER.; ZOOM 71.; ZOOM 88 ACCESS CATHETER.
• Patient Age: 88 YR
• Patient Sex: Female