MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM¿ 88 LARGE DISTAL PLATFORM; GUIDE CATHETER

Model Number	ICTC088110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.The lot number was not provided by the user facility.All devices undergo testing and inspection confirming devices meet specifications prior to release.Based on the information provided, a carotid cavernous fistula (ccf) occurred during the recanalization procedure in the cavernous region where there were aneurysms and atherosclerosis.Per the procedure note, there was no evidence of catheter perforation through the vessel or any mention of catheters tracking in an unexpected fashion to result in a vessel perforation.There was no treatment of the ccf performed.Per the physician, the procedure was well-tolerated by the patient.There were no device issues reported related the zoom 88 device.The instruction for use warns user that "extreme caution should be used if it is required that the zoom 88 be advanced near or through any aneurysms or other vascular malformations".
Event or Problem Description
A patient with a history of atrial fibrillation, extensive cerebrovascular disease was being treated for a carotid terminus occlusion with the clot in the internal carotid artery (ica) terminus.When advancing the zoom 88 catheter past an aneurysm that was not initially visualized, a perforation of the aneurysm occurred creating a cavernous carotid fistula (ccf).There was no treatment performed for the ccf.The terminus clot was successfully removed, and vessel perfusion restored.Per the case notes provide by the physician, right femoral artery was percutaneously accessed with a 4f micropuncture set and a short 8f sheath was then placed.5f diagnostic catheter was advanced over an angled guidewire into the aortic arch for the initial angiogram.Imaging showed extensive intracranial and extra cranial atherosclerotic disease and extensive plaque throughout the carotid bulb with a high-grade stenosis at the left common carotid artery and cervical internal carotid.Diagnostic catheter was then exchanged for a zoom 88 over guidewire which was advanced into the distal cervical left ica.A zoom 71 was then advanced over a 0.16" guidewire, and advanced just beyond the clot under suction, with the zoom 88 also advanced to the cavernous supraclinoid junction at about the level of the occlusion.Aspiration thrombectomy was started and continued for approximately 1 min.Zoom 71 was removed and follow-up angiogram obtained through the indwelling guide sheath showed recanalization of the left middle cerebral artery (mca) and shunting of blood into the cavernous sinuses due to a perforation.Several left ica images showed filling of nearly all mca and left a1 segment was patent.There was a residual clot within the mid to distal a2 segment of the anterior cerebral artery (aca).No further thrombectomy was attempted due to the presence of the carotid rent ccf as well as the distal location of the residual aca clot.Final tici2b was achieved.A residual ccf was observed at the completion of the procedure.There was no evidence of any intracranial extravasation.There was no treatment of the ccf.Per the case notes provided by the physician, the procedure was well-tolerated.

• Brand Name: ZOOM¿ 88 LARGE DISTAL PLATFORM
• Common Device Name: GUIDE CATHETER
• 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: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 14877126
• Report Number: 3014590708-2022-00013
• Device Sequence Number: 12185014
• Product Code: QJP
• UDI-Device Identifier: 00812212030368
• UDI-Public: 812212030368
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K212224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: ICTC088110
• Device Catalogue Number: ICTC088110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FR DIAGNOSTIC CATHETER; FATHOM 16 GUIDEWIRE; ROSEN WIRE; ZOOM 71
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male