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	10/04/2020
Type of Reportable Event	Death
Additional 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, and 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 vessel dissection is unknown, and it cannot be determined if zoom catheter caused or contributed to the adverse event.
Event or Problem Description
The patient was undergoing a thrombectomy procedure on (b)(6) to treat occlusion within the left internal carotid artery (ica) terminus.Patient had a fetal posterior communicating (pcom) artery present.The zoom 088t 110cm catheter was delivered to the ostium of the fetal pcom.A total of three passes were performed.The first two passes were made with aspiration using the zoom 71 reperfusion catheter which had advanced to the mca over a competitor microcatheter and guidewire.The mca looked irregular prior to the third pass.The third pass was performed with a competitor stent retriever.Upon final imaging run a dissection was noted in the middle cerebral artery (mca) as well the ica.At the time of thrombectomy no interventions or follow up treatments were scheduled for the patient.It is not known if the zoom catheters caused or contributed to the vessel dissections.Patient expired three post operative days on (b)(6), and the relationship between the vessel dissection and the patient death is unknown.The cause of patient death 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
• MDR Report Key: 10833253
• Report Number: 3014590708-2020-00004
• Device Sequence Number: 3501745
• Product Code: DQY
• UDI-Device Identifier: 00812212030177
• UDI-Public: (01)00812212030177(17)210609(10)EPO060620-01
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180169
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: ICTC088110
• Device Catalogue Number: ICTC088110
• Device Lot Number: EPO060620-01
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR