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	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the treating physician that a zoom 71 catheter broke during a thrombectomy procedure.A patient was treated for an occlusion at the terminus.Access was obtained with a third-party access catheter over a guidewire.A zoom 71 catheter and a third-party microcatheter were advanced over the guidewire through the access catheter to the face of the clot.Aspiration was then applied.While retracting the zoom 71, the physician felt resistance.Fluoroscopy showed that at the common carotid artery, the zoom 71 catheter had bent on itself at the bifurcation of the internal and external carotid arteries.The physician attempted to retract the zoom 71 but was unsuccessful.The physician removed the access catheter, guidewire, microcatheter and zoom 71 together as a system from the patient.Once removed, the physician found that the end of the zoom 71 was "holding on by a string to the rest of the catheter".A new replacement zoom 71 was used to complete the procedure and the clot was removed successfully.The patient achieved partial reperfusion with a tici 2b score.No patient sequelae were reported.
Additional Manufacturer Narrative
The zoom 71 catheter was returned for investigation.Investigation confirmed the reported shaft breakage that occurred and suggested that an axial force was applied, stretching the shaft materials prior to breaking.Investigation demonstrated stretching and kinking on both the distal and proximal segments of the catheter shaft near the location of the break.The distal and proximal segments of the catheter were held by a thin segment of catheter material.Based on the provided complaint information, review of the case images and without the return of the competitor's adjunctive device, the exact root cause could not be determined.The most likely cause is related to the retraction of the zoom 71 into the access catheter with the access catheter positioned near the bifurcation of internal and external carotid arteries.This resulted in the reported feel of retraction resistance, catheter buckling and shaft break of the zoom 71.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: 20206618
• Report Number: 3014590708-2024-00033
• Device Sequence Number: 7583899
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/12/2024

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: 06/08/2026
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2409203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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: PHEONOM 21.; SYNCHRO 2 WIRE.; ZOOM 71.
• Patient Sex: Unknown