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

Model Number	ICRC035158
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imperative care, inc.Received the proximal segment of the zoom 35 catheter for investigation.Investigation confirmed shaft breakage and suggested that an axial force was applied during the procedure, stretching the shaft materials prior to the device breaking.Investigation determined that a distal segment of the zoom 35 had broken off from the catheter and was not returned.Investigation demonstrated stretched coil, and outer jacket at the break location.Additionally, there were kinks present in the distal section of the catheter.Further follow-ups with the customer determined that there was no evidence of tortuous anatomy, stenosis/calcification, abnormal interaction between adjunctive devices, or use error contributing to the complaint.Based on the complaint information provided and device investigation the exact root cause could not be determined.The manufacturing records for the zoom 35 were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
Access was obtained with a tracstar access catheter over a guidewire during an evaluation of a patient with iih (idiopathic intracranial hypertension).The tracstar was parked at the internal jugular vein.A zoom 35 was advanced through the tracstar into left transverse venous sinus without issue.The zoom 35 was then advanced across to the right sigmoid venous sinus over the guidewire.The guidewire was removed and zoom 35 hub was connected via tubing to the acist contrast injector machine.No contrast was injected.The physician intended to use the zoom 35 for diagnostic purposes; to measure the venous pressure throughout various locations in the venous sinus anatomy.Multiple measurements were taken to look for a large change in pressures throughout the venous sinus anatomy.While retracting only the zoom 35 back to the left venous sinus, the treating physician felt resistance.As a result, the physician retracted both the tracstar and zoom 35 together as a system.The physician saw, under fluoroscopy, that the inner coil of the zoom 35 had unraveled, and it was "trailing" the zoom 35 tip.The entire zoom 35 was removed with the tracstar, and both catheters were removed together from the patient without any patient complications.There was no major tortuosity or presences of stenosis/calcification observed, and there were no pre-existing implants present.There were no kinks observed on the tracstar or zoom 35, and no issues with the other devices.A new tracstar and a new zoom 35 were used to successfully complete the procedure without any patient complications.As a precautionary step, the physician performed a complete scan of the patient, and no foreign objects were observed.No patient sequelae 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: 17927909
• Report Number: 3014590708-2023-00030
• Device Sequence Number: 20481847
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/12/2023

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: 03/16/2024
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: F2304201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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: GLIDEWIRE 0.035"; PENUMBRA SELECT CATHETER; SYNCHRO SELECT .014"; TRACSTAR 95
• Patient Sex: Unknown