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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3014590708-2024-00008
• Device Sequence Number: 5741072
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K211476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 014 SYNCHRO WIRE.; XD 27 MICROCATHETER.; ZOOM SUPPORT.
• Patient Sex: Unknown