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

Model Number	ICRC055137
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for investigation.The manufacturing records for the zoom 55 were reviewed and demonstrated that the product met all the design and manufacturing specifications.The complaint of a shaft break could not be confirmed, and the exact root cause could not be determined as the device was not returned for analysis and no images were provided.
Event or Problem Description
A 61-year-old female patient was treated for an occlusion at the left middle cerebral artery.The patient was described as having an arch type that included a 120-degree turn and was extremely tortuous at the cervical region, close to the origin of the internal carotid.Access was obtained with a zoom 88 access catheter, a zoom 55 aspiration catheter, and a stent retriever.During the first pass, the zoom 88 was parked in the cavernous, distal to the internal carotid artery.The zoom 55 and stent retriever were advanced to the clot without encountering any resistance.After capturing some of the clot with the stent retriever, aspiration was applied to the zoom 55.Both the stent retriever and zoom 55 were then retracted through the zoom 88 and removed from the patient.No issues were reported during the first pass.On the second pass, the same zoom 55 and stent retriever were used and were able to partially engage with the clot.Aspiration was again applied to the zoom 55.Then zoom 55 and stent retriever were retracted through the zoom 88 and removed from the patient.While cleaning the zoom 55 at the back table, the technician noticed that the tip had unraveled but was still attached, with no missing parts.The zoom 88 was then removed from the patient, and a third-party system was used to remove the entire clot.The patient achieved complete reperfusion with a tici 3 score.No patient sequelae were reported.

• 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: 18700238
• Report Number: 3014590708-2024-00003
• Device Sequence Number: 7395303
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/13/2024

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: 06/08/2024
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2315701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2023
• 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: CAT 5 CATHETER; INFINITY ACCESS CATHETER; TREVO STENT RETRIEVER; TREVO TREK 21 MICROCATHETER; ZOOM 88
• Patient Age: 61 YR
• Patient Sex: Female