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

Model Number	ICRC035158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were discarded after use and therefore not available for return and investigation.There were no device deficiencies reported related to the zoom 88, zoom 55, or zoom 35.Based on the information provided and without case images, the exact cause of the subarachnoid hemorrhage (sah) is unknown.The relationship with the zoom device to the sah could not be established.It is unclear if the sah was caused by the zoom devices, the microwire, the third-party microcatheter, or tenecteplase.The manufacturing records for the zoom devices were reviewed and demonstrated that the product met all the design and manufacturing specifications.The following mfr # were submitted: mfr # 3013590708-2024-00005 for zoom 88 mfr # 3013590708-2024-00006 for zoom 55 mfr # 3013590708-2024-00007 for zoom 35.
Event or Problem Description
A 57-year-old male was treated for a left internal carotid artery (ica) terminus occlusion.A small skin incision was made, and an 8 french sheath was placed.Access was obtained with a guidewire, third-party catheter, and a zoom 88.During the first pass, the zoom 88 was navigated to the left ica to terminus over the guidewire while pump aspiration was applied.The zoom 88 catheter was withdrawn until free flow of blood was obtained.Angiography was performed.During the second pass, a zoom 55 was navigated over a third-party microcatheter and microwire into the left m2 inferior division occlusion through the zoom 88.Aspiration was applied to the zoom 55.The zoom 55 was removed, and angiography was performed.A third pass was attempted with a zoom 35 catheter advancing over a microwire; however, the catheter could not be navigated distally enough to engage the clot.The zoom 88, zoom 35, and the microwire were removed as a system from the patient.Hemostasis in the right groin was obtained.The patient achieved partial reperfusion with a tici 2b.There was no report of a device malfunction.Approximately 20 minutes later, a dyna-ct scan revealed a small amount of subarachnoid hemorrhage (sah).The patient received tenecteplase reversal protocol.The treating physician could not confirm whether the sah was caused by any of the devices used during the case or the tenecteplase the patient had received outside hospital.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: 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: joy patel ; 1359 dell; campbell, CA 95008-6609
• MDR Report Key: 18692029
• Report Number: 3014590708-2024-00007
• Device Sequence Number: 12564154
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2024

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: ICRC035158
• Device Catalogue Number: ICRC035158
• 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: Not provided
• Initial Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: GLIDEWIRE ADVANTAGE; PHENOM 27; SYNCHRO MICROWIRE; VTK; ZOOM 55; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 93 KG