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 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

Zoom 71 was returned for investigation and no third-party devices were returned.Upon investigation it was confirmed the shaft of the zoom 71 had broken.The break showed limited stretching of catheter materials.The proximal section of the zoom 71 catheter shaft was observed to be kinked.Based on the complaint information provided, and without the third-party devices being returned, the exact root cause could not be determined.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.The sequence of device preparation steps in the zoom instruction for use states to remove the zoom catheter from the pouch card and protective tubing prior to hydration and insertion of adjunctive devices.

Event Description

During preparation, a zoom 71 aspiration catheter was flushed while still in the packaging hoop.A guidewire and third-party microcatheter were hydrated outside of the zoom 71.The guidewire and third-party microcatheter were then advanced into the zoom 71 while the zoom 71 remained in the packaging hoop.The technician pulled the construct of the zoom 71, third-party microcatheter, and guidewire from the zoom 71 packaging hoop.There was slight friction experienced when removing the devices as a system.Upon removal from the packaging hoop, the zoom 71 was found to be separated.Another zoom 71 was prepped and used to complete the case without any issues.The patient is reported to be stable without any sequelae.

• 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: 18727434
• MDR Text Key: 335764114
• Report Number: 3014590708-2024-00008
• Device Sequence Number: 1
• Product Code: NRY
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2326303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• 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: 014 SYNCHRO WIRE.; XD 27 MICROCATHETER.; ZOOM SUPPORT.