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

Model Number ICRC071137

Device Problem Break (1069)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device was discarded after use and therefore not available for return and investigation.There were no images of the case provided.Currently the root cause of the shaft breakage is unknown.Based on the reported information, the patient had a type iii arch and a cervical loop.Additionally, the guide catheter had kinked at the cervical loop and resistance was felt while advancing and retracting the zoom 71.Per zoom 71 instructions for use: "do not advance or withdraw the zoom catheter or accessory/adjunctive devices against resistance without careful assessment of cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation and torquing the device against resistance may result in damage to the vasculature or the device" and "do not use kinked devices." since the device was not returned for investigation and no case images provided, the exact root cause of the shaft breakage is unknown.The manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed to ensure the device met minimum tensile specification and is kink resistant.The distal section undergoes 100% visual inspection for visual defects.

Event Description

The patient was undergoing a thrombectomy procedure to treat an occlusion within the middle cerebral artery (mca) m1 segment.Per the physician, the patient had a type iii arch and a cervical loop.The tracstar was parked at the high cervical loop.A kink was observed on the tracstar at the cervical ica under fluoroscopy.During first pass, resistance was felt on the zoom 71 while advancing the catheter beyond the kinked section of the guide catheter.The physician was able to advance the zoom 71 through the guide catheter.Upon retrieval, the physician felt significant resistance and continued to pull the zoom 71 into the guide catheter under heavy resistance.Upon removal, it was noted that the shaft of the zoom 71 had separated but all the of zoom 71 catheter was retrieved.The tracstar was removed and replaced with a competitor guide catheter.According to the doctor the competitor's guide catheter also kinked.A total of two passes were made.Post procedure, the patient was reported to be stable.

• 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: 13779497
• MDR Text Key: 292054994
• Report Number: 3014590708-2022-00005
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2132201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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: NEURON MAX.; TRACSTAR 088 LDP.