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	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A 78-year-old male was treated for an occlusion at the right ica (internal carotid artery) m1 segment.The zoom 88 access catheter was inserted into an 8 french (fr) sheath through a third-party rhv (rotating hemostasis valve).The third-party rhv was reported to have a smaller inner diameter 0.096" (2.44mm)/7.3fr than the zoom 88 catheter outer diameter of 0.110" (2.8 mm)/8fr.During the introduction, the zoom 88 became stuck in the rhv and the catheter broke.The location of the break is approximately 15cm from the distal end of the zoom 88.The rhv and zoom 88 were removed.The separated segment remained inside the rhv and did not enter the patient.A balloon guide catheter was used to continue with the procedure.The clot was successfully removed.The patient was reported to be in stable condition.No patient sequelae were reported.
Additional Manufacturer Narrative
The zoom 88 catheter was returned for investigation.The catheter was received broken into two segments with the distal segment stuck in a third party rhv.Investigation demonstrated complete separation of the catheter segments and suggested that an axial force was applied during the procedure, breaking the device into two segments.The distal segment break location of the catheter was just proximal to the rhv opening and had a section of coils with minimal stretching of catheter materials.The proximal segment break location showed a clean break with minimal stretching of catheter materials at the break location.Based on the information provided and investigation of the returned device, the break resulted from inserting a larger size catheter into a smaller internal diameter rhv.The manufacturing records for the zoom 88 were reviewed and demonstrated that the product met all the design and manufacturing specifications.

• 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: 17561183
• Report Number: 3014590708-2023-00025
• Device Sequence Number: 20553084
• Product Code: QJP
• UDI-Device Identifier: 00812212030368
• UDI-Public: 00812212030368
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: ICTC088110
• Device Catalogue Number: ICTC088110
• Device Lot Number: F2300502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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: 8FR COOK SHUTTLE 80CM; MERIT MEDICAL RHV (FLO40XR); Q'APEL WALRUS
• Patient Age: 78 YR
• Patient Sex: Male