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

Model Number	ICTC088110
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for investigation.The manufacturing records were reviewed and demonstrated that the product met all the design and manufacturing specifications.Based on the reported information, the rupture was at the ica.However, review of the case images provided by the site showed that the zoom 88 remained proximal to the ophthalmic and remote from the vessel rupture site.The zoom 88 did not appear to ever go distal to anterior cavernous segment of ica.There were no device deficiencies reported.
Event or Problem Description
A 62-year-old female patient was found to have an occlusion on the carotid terminus.Access was obtained with a zoom 88 catheter, a competitor microcatheter, and guidewire.The zoom 88 was positioned proximal to the carotid terminus (below the level of the ophthalmic).A zoom 71, zoom 35, and another guidewire were advanced towards the clot and three passes were performed with the zoom 71.The zoom 71 and zoom 35 were then removed from the guide catheter.For the fourth pass, a solitaire stent retriever was advanced past the carotid terminus through the clot and then removed from the zoom 88.Then 8cc of contrast was administered with a 10cc syringe through the zoom 88.Imaging showed a vessel rupture at the carotid terminus/ internal carotid artery (ica).A hyper occlusion balloon, coils, and an external ventricular drain were used to treat the rupture.The treating interventional radiologist (ir) believes the rupture was due to 8cc of contrast delivered to a closed space high above the occluded petrous.However, the ir could not rule out the stent retriever, guidewire, or the zoom 88 as the cause.The physician did not find any damage to the zoom 88, zoom 71, or zoom 35 devices.The patient passed away approximately two days after the procedure.The physician attributed the death to complications from the vessel rupture.
Additional Manufacturer Narrative
Update to the following fields: d9, g3, g6, and h3 corrected field a2 from 66 years to 67 years.The zoom 88 catheter was returned for investigation.The investigation showed no device deficiencies related to the zoom 88 catheter.The inspection confirmed the product met all specifications.
Event or Problem Description
Refer to h10 for follow-up information.

• 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 ave; campbell, CA 95008-6609
• MDR Report Key: 16773465
• Report Number: 3014590708-2023-00010
• Device Sequence Number: 16929026
• Product Code: QJP
• UDI-Device Identifier: 00812212030368
• UDI-Public: 00812212030368
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2023
• Device Model Number: ICTC088110
• Device Catalogue Number: ICTC088110
• Device Lot Number: F2225802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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: 0.035" GUIDEWIRE; ARISTOTLE 0.014" GUIDEWIRE; SIM SELECT CATHETE; SOLITAIRE 6X40 STENT RETRIEVER; ZOOM 35 CATHETER; ZOOM 71 CATHETER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female