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

Model Number	ICRC071137
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the physician that a patient was treated for a posterior clot in the vertebral artery.Left radial access was obtained using a zoom rdl access catheter.During the first pass, the zoom 71 was advanced to the face of the clot in the v1 & v2 segment.Aspiration was applied to the zoom 71 for approximately 2 minutes using a zoom pump.While retracting the zoom 71 through the zoom rdl the physician felt resistance.The physician assumed that the zoom rdl might have kinked, so he slowly pulled back the zoom rdl to straighten the catheter.He successfully retracted the zoom 71 through the zoom rdl.Upon removal, the physician observed that the zoom 71 shaft had separated and was held together by a nitinol coil.A replacement zoom 71 was advanced through the same zoom rdl to continue with the procedure.A second pass was performed, and the clot was successfully removed.The patient achieved complete reperfusion with a tici 3 score.The patient was reported to be stable without any patient sequelae.
Additional Manufacturer Narrative
The zoom 71 and zoom rdl catheters were returned for investigation.Investigation confirmed the reported shaft break on the zoom 71.Investigation demonstrated stretching and kinking on both the distal and proximal segments of the catheter shaft near the location of the break.Visual inspection of the returned zoom rdl showed a kink on the mid-shaft of the catheter.It is unknown at what point in the procedure or transport of the rdl to imperative care the kinked occurred.Based on the provided complaint information the most likely cause for shaft break is related to retraction of the zoom 71 against resistance through a constriction.The manufacturing records for the zoom 71 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: 20569607
• Report Number: 3014590708-2024-00035
• Device Sequence Number: 18012741
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/30/2024

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 Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ONYX CORONARY STENT; ZOOM RDL
• Patient Sex: Unknown