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

Model Number ICRC071137

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

The device was discarded after use and therefore not available for return and investigation.A device lot number was not provided.All devices undergo appropriate testing and inspection per standard manufacturing processes to ensure the device meets specifications prior to release.Based on the complaint information and with no device images provided, the exact root cause for the "vessel dissection" could not be determined.It was reported that both the stent retriever and zoom 71 were present at the location of the dissection.Additionally, the dissection was identified at the clot location.Therefore, it is unknown if the dissection was preexisting.No device deficiencies reported related to the zoom device.

Event Description

A patient was being treated for a mechanical thrombectomy of the m1 segment of the middle cerebral artery.A third-party guide catheter was used to access the site and was parked in the cervical area.A third-party microcatheter and stent-retriever were advanced to the clot location.After two unsuccessful attempts to capture the clot, the third-party microcatheter and stent-retriever were completely removed.The treating physician then advanced a zoom 71 aspiration catheter over the guidewire to the face of the clot.The guidewire was removed, and aspiration was applied to the zoom 71.The clot was successfully removed.The patient achieved complete reperfusion with a tici 3 score.Following the final pass, imaging showed a vessel dissection at the site of the clot.The physician believed the dissection was non-flow limiting and no additional treatment or intervention was performed.Due to the presence of the third-party catheter, stent-retriever, and zoom 71 in the m1 segment, the physician is unsure which device may have caused the vessel dissection.Additionally, the dissection was at the clot location and was only noted after the clot was removed, the physician was unsure if the dissection was preexisting.There were no device deficiencies reported.Two weeks post procedure, the patient presented with unspecified symptoms.The physician decided to implant a flow diverter to cover the dissection.The patient was reported in stable condition.

• Brand Name: ZOOM REPERFUSION CATHETER
• Type of Device: 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: 18166198
• MDR Text Key: 328479784
• Report Number: 3014590708-2023-00034
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2023

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
• Device Operator: Health Professional
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PENUMBRA RED 68 CATHETER; TREVO STENT RETRIEVER
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: White