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

Model Number ICRC045144

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

Patient Problem Vascular Dissection (3160)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is available for return.Without the return of the device, the root cause of the problem cannot be determined.The lot number was not provided.All product is subjected to testing and inspection to ensure the device tip is atraumatic, and the distal section of the catheter undergoes 100% visual inspection and is free of visual defects or protrusions.Potential adverse events related to zoom reperfusion catheters include, but are not limited to, the following: intracranial hemorrhage, vessel spasm, dissection, perforation, rupture, including death.

Event Description

During navigation through a hairpin loop in the internal carotid artery (ica) using a zoom 45 and competitor microcatheter, operator observed a vessel dissection.Patient status is currently unknown.It is unknown if there was any treatment to address the dissection.

• 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: justin ou ; 1359 dell avenue; campbell, CA 95008-6609 ; 6692003985
• MDR Report Key: 12271957
• MDR Text Key: 264938794
• Report Number: 3014590708-2021-00013
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VELOCITY DELIVERY MICROCATHETER