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

Model Number	ICRC071137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was retained by the user facility and not returned to imperative care.Therefore, there is no additional information available.The manufacturing records of 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 met minimum tensile specification.The catheter undergoes 100% visual inspection for visual defects over the entire length of the catheter.
Event or Problem Description
Patient presented with right m1 occlusion.Physician accessed the right femoral with access catheter.The access catheter was navigated to the right internal artery just distal to the bifurcation of the external over a 5fr select catheter and a.035 guidewire (gw).The select catheter and 0.035" gw were removed.0.014" gw, zoom 71 and a 0.017" microcatheter (mc) were advanced to the cavernous carotid segment of the right ica.The mc and gw were advanced to the distal mca territory and the zoom 71 was advanced to the m1 segment just proximal to the clot.A stent retriever was advanced through the empty mc to the location of the clot and deployed.Aspiration was started and it was noted that the zoom 71 was not corked.After a few minutes the stent retriever and zoom 71 were removed from the patient and clot was noted on the stent retriever.For the second pass, the 0.14 " gw, mc and zoom 71 were re-introduced into the access catheter and navigated to the cavernous carotid segment of the ica.The gw and mc were then navigated to the distal mca territory and the zoom 71 was advanced to the m1 segment.During this advancement physician mentioned having difficulty advancing the zoom 71 as was evidenced by the mc and gw retracting to the m1 segment.The patient became bradycardic at this time.Physician then panned down to the carotid bifurcation that was not visible on the treatment view and it became evident that the access catheter, zoom 71 and mc had been advanced to a position that was now in the external carotid artery with the distal end of the zoom 71 and mc doubled over and looping back into the ica.Upon retraction of the zoom 71 the distal end moved only slightly proximal then stopped while the proximal end of the catheter was removed from the patient.It was noted that the catheter had separated.A snare device was introduced into the access catheter and the distal end of the zoom 71 was quickly snared retracted into the distal end of the access catheter.Both the access catheter and zoom 71 were successfully removed from the patient and pressure was held.Post-surgery, the patient was doing well and not experiencing any adverse events due to the separation of the catheter.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE; 1359 dell ave; campbell CA 95008 6609
• MDR Report Key: 12170727
• Report Number: 3014590708-2021-00012
• Device Sequence Number: 13861117
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: 01008122120301911722012210F
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K210996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2100802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1