MAUDE Adverse Event Report: IMPERATIVE CARE, INC. ZOOM71; CATHETER, THROMBUS RETRIEVER

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Fracture of zoom71 aspiration catheter during stroke mechanical thrombectomy.Patient taken for emergent mechanical thrombectomy.Thrombus notably resistant to treatment.Zoom71 stroke aspiration catheter used for primary treatment (aspiration, unsuccessful) and then used with stent retriever devices.During 3rd attempt with zoom71 device (second stent retriever attempt), on withdrawal, the zoom71 fractured inside the guide catheter and distal tip remained in patient's internal carotid artery.Ultimately, device was able to be withdrawn with guide catheter without retained product.

• Brand Name: ZOOM71
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE, INC.; campbell CA 95008
• MDR Report Key: 16312174
• MDR Text Key: 309052164
• Report Number: MW5114734
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOTRAP REVASCULARIZATION DEVICE.; SOLITAIRE STENT RETRIEVER.; WALRUS BALLOON GUIDE CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American