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 09/26/2023

Event Type  Injury  

Manufacturer Narrative

Based on case images and information provided, a severe kink was noticed on the rdl within the right subclavian area.During retraction, the physician encountered resistance but continued to remove the zoom 55 through the kinked rdl, resulting in the zoom 55 separating.Post procedure device imaging showed the proximal portion of the zoom 55 was significantly stretched suggesting that an axial force was applied during retraction.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, the exact root cause of the separation could not be determined.However, it is likely the insertion and retraction through a kinked rdl guide catheter contributed to the zoom 55 separation.Imperative care inc.Has not received the device for evaluation.Therefore, the exact root cause of the customer reported issue has not been determined.

Event Description

A 26-year-old female patient was treated for an occlusion in the right m1 segment.Right radial access was obtained with a zoom rdl into the right internal carotid artery (ica).The zoom rdl was parked at the high cervical.A guidewire, a zoom 35, and a zoom 55 catheter were advanced through zoom rdl into the m1 segment without issue.The guidewire and zoom 35 were then removed from the patient.A clot pod tubing was connected, and aspiration was applied to the zoom 55 catheter.While retracting the zoom 55 through the zoom rdl, the team continued to feel resistance.The physician then noticed the tip of the zoom 55 was not retracting.The patient's anatomy was not tortuous, and there was no stenosis or calcification in the vasculature.Under fluoroscopy, a kink was discovered on the rdl at the right subclavian area.As the physician continued to retract the zoom 55 through the kinked rdl, a segment of the zoom 55 separated in the right middle carotid artery (mca).The zoom 55 was then removed from the patient, and it was found to be stretched.The physician estimated that a portion of the catheter broke at approximately 25-30 cm from the distal tip.The separated portion of the catheter still had the marker band attached and was found unwound and stretched.An angiogram revealed that the distal portion of the zoom 55 was in the ica.To remove the distal portion of the zoom 55, left femoral access was obtained using a short sheath, a third-party access catheter, and a third-party angiographic catheter into right ica.A snare was used to attempt to capture and remove the distal portion of the zoom 55 from the patient.The short sheath and third-party access catheter were exchanged and replaced with a different third-party access catheter and a guidewire.The new third-party access catheter, guidewire, and a stent retriever were used to successfully capture the clot in the m1 segment, and the patient achieved complete reperfusion with a tici 3 score.When obtaining the femoral angiogram for the groin closure, the physician decided to use manual pressure for sheath removal.Hemostasis was obtained and distal pedal pulses were checked; however, the patient exhibited no flow in the left distal pulses.X-ray imaging revealed that an unknown portion of the zoom 55 was in the femoral profunda.A decision was made to transfer the patient to vascular surgery.After the foreign body was removed, the patient was transferred to the intensive care unit where the patient remained sedated and intubated.To date, the patient remains stable and continues to recover in the hospital.

Event Description

Refer to h10 for follow-up information.

Manufacturer Narrative

Only the proximal and distal coiled segments of the zoom 55 were returned for evaluation.The segment reported to have the marker band attached unwound and stretched was not returned for evaluation.The investigation of both returned segments demonstrated damage which suggests an axial force was applied during the procedure, resulting in stretching of the shaft materials prior to the device breaking.Investigation demonstrated stretched coil and catheter jacket at the break locations on each returned segment.Additionally, both returned segments of the catheter had kinks present.The exact root cause for the broken shaft could not be confirmed.However, based on the reported complaint information, contributing factors to the zoom 55 shaft break complaint were a result of retraction of the zoom 55 against resistance and retraction of the zoom 55 through a kinked rdl guide catheter.

• 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 Key: 18000184
• MDR Text Key: 326445720
• Report Number: 3014590708-2023-00031
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2312501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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: 0.018" GUIDEWIRE; 0.035" GLIDEWIRE; 4MM ENSNARE; 4MM SOLTAIRE; 5FR ESPERANCE; 5FR SIM SELECT; 5FR VERTEBRAL CATHETER; 6FR NEURON MAX; 8X65 DESTINATION SHEATH; ZOOM 35
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American