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

Model Number ICRC071137

Device Problems Break (1069); Material Separation (1562)

Patient Problems Death (1802); Foreign Body In Patient (2687)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

The product is not available for return as it was discarded, however, the manufacturing records for this lot were reviewed, and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed to ensure the device tip is atraumatic, that the device met minimum tensile specification and is kink resistant.The distal section of the catheter undergoes 100% visual inspection and is free of visual defects or protrusions.At this time, due to the limited images and information available from the hospital the root cause of the marker band detachment is unknown.As the cause of death is respiratory, zoom 71 reperfusion catheter did not cause, or contribute to death.

Event Description

Patient was undergoing a thrombectomy procedure on (b)(3) to treat occlusion within the right middle cerebral artery (mca) m1 segment.Physician made three passes with the zoom 71 and zoom 35 combination.Complete revascularization was achieved after the third pass.Final angiogram was performed and at the time the physician did not observe any issues.Post operation the patient was doing better neurologically compared to pre operation.Mri was performed immediately following operation with no new infarction at mca, and anterior cerebral artery (aca) location.Based on improved conditions and no new infarction at mca and aca, the patient was discharged from the icu to the floor.Patient later expired due to an unrelated respiratory issue, and a ct scan was requested.A foreign body was identified, and the final angiogram following thrombectomy was reviewed and revealed the zoom 71 marker band in the (aca) territory.This was not evident at the time as the blood flow was not limited, or slowed.

• 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: 11023424
• MDR Text Key: 223814938
• Report Number: 3014590708-2020-00010
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 0081221203191
• UDI-Public: (01)0081221203191(17)211019(10)F2028801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2021
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2028801
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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
• Patient Age: 74 YR