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

Model Number	ICRC055137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was treated for an occlusion in the m1 segment.The patient had a type 1 arch, and the anatomy was not tortuous.Access was obtained with a guidewire and a zoom 88 access catheter to the distal petrous.During the first pass, a zoom 55 catheter was advanced through the zoom 88 to the face of the clot.Aspiration was applied, and the clot was removed successfully.Post aspiration imaging revealed another clot in the m2 segment.For the second pass, the same zoom 88 was advanced and parked in the proximal cavernous.The same zoom 55 was advanced through the zoom 88 to the face of the clot in the m2 segment.Aspiration was applied but unable to aspirate the clot successfully.A zoom 35 catheter was then advanced through zoom 55.Resistance was felt when advancing the zoom 35 through zoom 55.The physician then noticed under imaging that the zoom 35 and the zoom 55 were not moving independently.The zoom 55, zoom 35, and guidewire were removed from the patient as a system.Per the physician, the distal end and the soft part of the zoom 55 was "all bunched-up".After removal from the patient, the physician attempted to remove the zoom 35 from inside of the zoom 55 and found that the zoom 55 shaft had partially separated and was held together by "a thread".At the back table, the resident attempted to flatten out the "bunched-up" portion of the zoom 55, and in doing so, the two pieces became detached.In the third pass, the guidewire was advanced through the zoom 88 still in place and a new zoom 55 was used.The physician advanced the same zoom 35 through the new zoom 55.The zoom 55 was then advanced to the face of clot in the m2 segment.The clot was aspirated successfully without any issues.No patient sequelae were reported.
Additional Manufacturer Narrative
The zoom 55 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 along both the distal and proximal segments of the broken catheter shaft.Stretched catheter jacket materials were observed on both the distal and proximal segments of the zoom 55.Based on the complaint information provided, with no case images and without the return of the adjunctive devices, the exact root cause could not be determined.The manufacturing records for the zoom 55 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: 19536695
• Report Number: 3014590708-2024-00019
• Device Sequence Number: 20439237
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K210996
• 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): 06/13/2024

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: 05/11/2026
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2406703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: SYNCHRO STANDARD MICROWIRE; ZOOM 35; ZOOM 88
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White