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

Model Number	ICRC035158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.No device deficiencies were reported related to the zoom 35 catheter.Based on the complaint information provided and with limited case images, the exact root cause of the rupture could not be determined.It is not clear if the rupture was caused by the zoom 35, the guidewire, or other reasons.A review of the manufacturing records for this lot did not reveal any issues pertaining to design, manufacturing, or quality.
Event or Problem Description
A 61-year-old male patient was treated for an occlusion at the m3 segment.Access was obtained using a third-party access catheter, which was parked at the cervical.During the first pass, a guidewire and a zoom 35 aspiration catheter were advanced through the third-party access catheter to the face of the clot without issue.Aspiration was applied to the zoom 35, and the clot was removed successfully.A post-contrast run showed additional clot in the m4 segment.For the second pass, the same zoom 35 and guidewire were advanced to retrieve the additional clot in the m4 segment.When advancing the zoom 35 to the clot, a rupture was observed under fluoroscopy.The rupture was coiled, and the procedure was completed.A follow-up computed tomography (ct) scan was performed, showing mostly contrast.The patient was then transferred to comfort care.At an unknown later date, the patient passed away.According to the physician, the cause of death was attributed to multiple pre-existing comorbidities and not to the bleed.There was no device malfunction reported against the zoom 35 catheter.

• 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: 20736243
• Report Number: 3014590708-2024-00040
• Device Sequence Number: 8287413
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: UNKNOWN
• 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: 10/24/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ARISTOTAL 24 GUIDEWIRE; BALT BALLAST ACCESS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male