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); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 71-year-old male patient was treated for an occlusion at the left proximal m2 segment.Access was obtained using a zoom 88 support catheter through a short 8f sheath to the proximal petrous turn.The physician steam shaped the tip of a zoom 71 aspiration catheter before advancing it through the zoom 88 support without a guidewire or microcatheter to the face of the clot.Aspiration was applied with a 60cc vac-lock syringe for approximately 60 seconds.While retracting the zoom 71 through the zoom 88 support, the physician indicated it felt "very smooth" with no resistance noted.As the physician continued to retract the zoom 71 through the zoom 88 support, he noted that the distal end of the zoom 71 was not retracting.Imaging revealed that approximately 15-20 cm of the distal end of the zoom 71 catheter was still in the patient's middle cerebral artery (mca), with the tip terminating at the proximal m2 segment.The zoom 71 separated at the proximal end of the zoom 88 support and was held together by the coil.The separated zoom 71 segment was successfully removed from the patient using a third party microcatheter and snare device.The clot in the m2 segment was removed and the case was completed.The patient was reported stable without any patient sequelae.
Additional Manufacturer Narrative
The zoom 71 catheter was returned for investigation in three pieces: distal and proximal segments and tangled portion of catheter material.Investigation confirmed the reported shaft break.The investigation found stretching and kinking along both the distal and proximal segments of the broken catheter shaft.Investigation of the distal tip of the zoom 71 confirmed that it was modified and was shaped at an angle.The surface of the shaped section did not appear smooth when compared to an un-shaped zoom 71.Based on the reported complaint information and location of the break compared with the distal tip of zoom 71, it cannot be confirmed that the shaped tip contributed to the complaint.Based on the complaint information and images provided, the exact root cause could not be determined.The most likely cause was retraction of the zoom 71 through a constriction.However, the adjunctive devices were not returned for confirmation.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.

• 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: 20518216
• Report Number: 3014590708-2024-00034
• Device Sequence Number: 15656160
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2026
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2409603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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: 60 CC VACLOCK SYRINGE.; SHORT 8F SHEATH.; ZOOM 88 SUPPORT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American