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	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoom 71 catheter was returned for investigation.Investigation confirmed the reported shaft breakage.Investigation demonstrated stretching and kinking along both the distal and proximal segments of the broken catheter shaft indicating that an axial force was applied.Stretched catheter jacket materials were observed on both the distal and proximal segments 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.Based on the complaint information provided and device investigation the exact root cause could not be determined.A contributing factor to the zoom 71 damage is attributed to the presence of stenosis at the carotid bulb that potentially interfered with the retraction of the zoom 71 resulting in the catheter shaft stretching.
Event or Problem Description
The patient first underwent a middle meningeal artery (mma) embolization procedure to address a subdural hematoma resulting from a fall.Radial access was achieved using a third-party access catheter and microcatheter for coil deployment.Following the mma embolization procedure, a mechanical thrombectomy procedure was performed to remove the occlusion located at the right mid-middle cerebral artery (mca).The patient's anatomy was tortuous, and stenosis was observed just distal to the carotid bulb, before the external carotid artery (ca).During the first pass, access was obtained using an rdl, a 0.038" glidewire, and a third-party select catheter.The rdl was parked at the mid-external ca.A zoom 71 was advanced to the face of the clot, and after removing the third-party select catheter, aspiration was applied.While retracting the zoom 71 through the rdl resistance was felt (location of the resistance was not specified).The treating physician noticed under fluoroscopy that the zoom 71 had stretched proximal to the tip.The entire zoom 71 and rdl were successfully removed together as a system.The patient achieved complete reperfusion with a tici 3 score.Post procedure, the patient was stable with no reported sequelae.At the back table, when the technician attempted to separate and pull the zoom 71 through the rdl, the zoom 71 shaft fractured (exact location of the break was not provided).

• 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: 19217390
• Report Number: 3014590708-2024-00016
• Device Sequence Number: 17873338
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/30/2024

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: 11/02/2024
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2329902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: 0.038" GLIDEWIRE; ECHELON MICROCATHETER; EXPEDION MICROWIRE; RDL; SIM2 SELECT0401; ZOOM 35
• Patient Sex: Female