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

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.

• 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: 18187968
• MDR Text Key: 328739132
• Report Number: 3014590708-2023-00033
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211476
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2313901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER.; STENT RETRIEVERS.; V18 GUIDEWIRE.; ZOOM RDL.
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female