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

Model Number	ICRC055137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion in the right internal carotid artery (ica) m1 segment.Access was obtained with a guidewire, third- party microcatheter, and zoom 88.The zoom 88 was positioned within the ica (exact location was not provided).During pass 1, the guidewire and microcatheter were replaced with a new microwire and zoom 35.The zoom 55 was advanced over the zoom 35 to the clot location.Aspiration was applied to the zoom 55, and part of the clot was captured.A mtici 2a recanalization was achieved.The distal clot remained in the m2 segment.The physician used the same devices and same approach as in pass 1 for passes 2 through 5.At the end of pass 5, the distal clot in the m2 segment was aspirated with a final mtici 2b score.There was no evidence of vessel dissection, contrast extravasation, emboli in new territories, or other untoward events.The patient tolerated the procedure well, remained stable, and was subsequently transferred to intensive care unit (icu).There was no device malfunction or patient sequelae reported.Approximately four hours after the first thrombectomy case, the patient developed worsening symptoms and imaging showed a new right cervical ica occlusion and re-occlusion of the right m1 segment.The patient underwent a second thrombectomy procedure.Carotid access was obtained with a guidewire, third-party microcatheter, and zoom 88.During pass 1, the zoom 88 was advanced to the face of the clot in the right cervical ica.The microcatheter and guidewire were removed, then aspiration was applied.Some clot was captured and aspirated, but the diastaltic remained occluded.During the second pass, a zoom 71 catheter was advanced over a zoom 35 and microwire to the face of the clot.Aspiration was applied to the zoom 71, capturing part of the clot and achieving mtici 2a score.The distal right ica was recanalized; however, the m1 segment was still occluded.During the third pass, the same zoom 71 catheter was advanced over the microwire to the face of the clot.Aspiration was applied to the zoom 71 and the m1 segment was recanalized with mtici 2a score.Residual clot was still present in the m2/m3 segment.During the fourth pass, the zoom 71 was replaced with a zoom 55 catheter, which was advanced over a microwire to the face of the clot in the m2 segment.Aspiration was applied to the zoom 55 and mtici 2b achieved.Using the same approach and the same devices as in the fourth pass, aspiration was applied; however, there was no change, and the final score of mtici 2b was achieved.A decision was made to conclude the procedure, which had lasted approximately 66 minutes.The patient was then moved to the icu.There was no device malfunction reported.The patient was discharged home six days later, on (b)(6), 2023.The treating physician reported that the re-occlusion was related to the device.
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.There were no device deficiencies reported related to the zoom 88, zoom 55, and zoom 35.The exact cause of the re-occlusion is unknown.The relationship with the zoom device to the re-occlusion could not be established.Based on the information, it is unclear if the re-occlusion was caused by the zoom products, guidewire, or third-party microcatheter.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 # 3013590708-2023-00035 for zoom 88.Mfr # 3013590708-2023-00037 for zoom 35.

• 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: 18315043
• Report Number: 3014590708-2023-00036
• Device Sequence Number: 6267284
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/12/2023

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: 05/08/2024
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2312301
• 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: 11/14/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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: 0.038 TERUMO LT GUIDEWIRE; 5-FR VTK SELECTION CATHETER; 8-FR 45CM LONG SHEATH; 8F ANGIO-SEAL; BENTSON GUIDEWIRE; ZOOM 35 MICROCATHETER; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 66 KG