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

Model Number ICRC071137

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Inspection results of the returned device confirmed that the marker band was separated from the catheter.Total length of returned device was 136.6cm.All other material were present on the returned catheter besides the separated marker band.Three kinks are present at 35.4cm from the tip, 33.2cm from the tip, and 27.1cm from the tip.Scrape marks were present on the outer diameter of the distal catheter from 27.1cm from the tip to the distal tip, with severe scrapes at 14.5cm from the tip.Scape marks on the outer diameter may indicate the catheter encountered obstruction and was pulled against resistance.The root cause of the detachment is unable to be determined based on the event information and images of the case.The manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection was completed to ensure the device met minimum tensile specification and is kink resistant.The distal section undergoes 100% visual inspection and is free of visual defects or protrusions.Without the return of the other devices used within this case, the root cause of the marker band detachment cannot be confirmed.

Event Description

Patient was undergoing a thrombectomy procedure on (b)(3) to treat occlusion within the right internal carotid artery (ica).Access was obtained with tracstar ldp access catheter.Zoom 71 reperfusion catheter was advanced to the clot location over a zoom 35 reperfusion catheter.First pass was made with the zoom 71 and zoom 35 in the carotid terminus without incident.Second pass was made in the right middle cerebral artery (mca) m1 segment using the zoom 71 and zoom 35 without incident as well.Physician noted distal clot in the right m3 segment of the mca, and with the zoom 71 placed at the distal m1 proceeded to advance the zoom 35 to the clot with aspiration turned on.The zoom 35 and the zoom 71 were retracted into tracstar ldp to be withdrawn from the patient.No resistance was noted at the time of withdrawal of the zoom 35 and zoom 71 into the tracstar ldp.Follow up angiography demonstrated that the marker band was detached and within the distal m1.At the time distal flow was noted, and no further intervention was performed.The case was completed with no additional clinical event.Patient was noted to be stable following the procedure.

• 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: 11023364
• MDR Text Key: 222324850
• Report Number: 3014590708-2020-00009
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: (01)00812212030191(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

• 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
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: No
• 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