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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was treated for an occlusion at the left m2 segment.The patient reportedly had a pre-existing dissection.Access was obtained with a zoom 88 access catheter over a guidewire.A zoom 55 and a third party microcatheter were advanced over the guidewire through the zoom 88.While attempting to perform the first pass, the treating physician noticed a tight turn in the horizontal cavernous causing the zoom 88 to press into the side of the zoom 55.When the physician tried to remove the zoom 55, the physician immediately felt resistance.The patient was noted to have a tortuous anatomy.After removing the zoom 55 completely through the zoom 88 access catheter and out from the patient, the physician found the outer jacket of the zoom 55 had separated however was connected via the coil.The physician released some tension off the zoom 88 and proceeded with the case using a zoom 71, third party microcatheter, and stent retriever successfully through the zoom 88.The clot was removed successfully.The patient achieved partial reperfusion with a tici 2c score and the patient was reported stable.No patient sequelae were reported.
Additional Manufacturer Narrative
The zoom 55 catheter was returned for investigation.Investigation demonstrated severe damage to the catheter shaft materials and suggested that an axial force was applied during the procedure, stretching the shaft materials prior to separation of catheter shaft segments.The proximal and distal segments of the catheter shaft demonstrated kinking, flattening, entanglement and stretching of coil and jacket material near the break locations.The proximal and distal catheter segments were held together by coil wire which makes up the catheter shaft.Based on the complaint information provided and device investigation 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: 17187286
• Report Number: 3014590708-2023-00020
• Device Sequence Number: 6809298
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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: 02/23/2024
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2304902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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: VELOCITY MICROCATHETER; ZOOM 71; ZOOM 88
• Patient Sex: Unknown