MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM 88-T LARGE DISTAL PLATFORM; CATHETER,PERCUTANEOUS

Model Number	ICTC088110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing an emergent intracranial mechanical thrombectomy for a left middle cerebral artery (mca) m1 large vessel occlusion.The zoom 088 catheter was placed into the left mca m1 segment over the zoom 071 aspiration catheter, 027 microcatheter and 014 guidewire.Aspiration catheter, microcatheter and guide wire were withdrawn.Catheter was connected to the aspiration tubing and mechanical aspiration was performed and withdrawn into the cervical ica.Follow up angiogram showed the ica was occluded.A second attempt was made using a 4 x40 stent retriever and zoom 71 aspiration catheter and some clot was removed.Follow up runs showed intimal dissection in the proximal left mca m1 segment.The patient received a bolus of integrilin and was placed on a drip to prevent thrombus at the dissection site.This was followed by intracranial angioplasty.The patient also received a large dose of ticagrelor to prevent thrombus.Prior to the procedure the patient had received tenecteplase.The patient's hospitalization was reportedly prolonged and the patient required prolonged antiplatelet therapy to treat this dissection.Per the treating physician, the dissection was likely due to initial placement of the zoom 88 catheter in the m1 mca.
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.There were no images of the case provided.The lot number was not provided by the user facility.All devices undergo lot release testing and inspection to ensure the device tip is atraumatic.Additionally, 100% of the catheters undergo visual inspection of the distal section to verify it is free of visual defects or protrusions.With the limited information available, no procedural images provided, and multiple devices used during the case, the exact root cause of the vessel dissection is unknown.

• Brand Name: ZOOM 88-T LARGE DISTAL PLATFORM
• Common Device Name: CATHETER,PERCUTANEOUS
• 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: 13510394
• Report Number: 3014590708-2022-00002
• Device Sequence Number: 17261590
• Product Code: DQY
• UDI-Device Identifier: 00812212030177
• UDI-Public: 00812212030177
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203764
• 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): 02/11/2022

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
• Device Lot Number: UNKNOWN
• 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: 01/13/2022
• Initial Report FDA Received Date: 02/10/2022
• 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: 014 GUIDEWIRE; 027 MICROCATHETER; 4X40MM STENT RETRIEVER; ZOOM 71
• Outcome Attributed to Adverse Event: Hospitalization; Other; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic