MAUDE Adverse Event Report: Imperative Care Inc. Zoom 88 Large Distal Platform Support, 100 cm

Model Number	ICTC088100S
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a carotid stent procedure, a zoom 88 support catheter became kinked approximately 14 cm from the distal tip while positioned in the iliac artery.During the first pass, resistance was encountered during advancement at which time the kink at 14cm was observed.Resistance was also encountered during retraction while attempting to exchange the catheter for a new zoom 88 support.As the physician attempted to withdraw the catheter, it fractured approximately 14 cm from the distal tip.A goose neck snare was used in an attempt to retrieve the detached catheter segment; however, retrieval was unsuccessful, and the fragment remained in the common iliac artery without limiting blood flow.Open surgical intervention was subsequently performed to access the iliac artery and retrieve the distal catheter fragment.The catheter segment was successfully retrieved, and the patient was reported to be alive following the procedure.
Additional Manufacturer Narrative
The zoom 88 support catheter was not returned for investigation.The manufacturing records reviewed for the product met the design and manufacturing specifications.Zoom ifu provides the following warning related to retraction against resistance."exercise care when manipulating the device through tortuous anatomy.Do not advance or withdraw the catheters or accessory/adjunctive devices against resistance without careful assessment of the cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation or torquing the device against resistance may result in damage to the vasculature or the device." based on the information available, the exact root cause for the shaft break could not be determined.

• Brand Name: Zoom 88 Large Distal Platform Support, 100 cm
• Common Device Name: Zoom 88 Large Distal Platform Support, 100 cm
• Manufacturer (Section D): Imperative Care Inc.; 1359 dell ave; campbell CA 95008 -660
• Manufacturer (Section G): Imperative Care Inc.; 1359 dell ave; campbell CA 95008 -660
• Manufacturer Contact: katharine treangen ; 1359 dell ave; campbell, CA 95008--660 ; +1(408)202-9060
• MDR Report Key: 50064306
• Report Number: 3014590708-2026-00028
• Device Sequence Number: 15982948
• Product Code: NRY
• UDI-Device Identifier: 00812212030573
• UDI-Public: (01)00812212030573(17)290423(10)F2611202
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K242672
• 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): 07/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICTC088100S
• Device Catalogue Number: ICTC088100S
• Device Lot Number: F2611202
• 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: 07/07/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2026
• 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: Abbott Critical Care Versacore Modified J (Wholey).; Abbott Emboshield NAV6.; Abbott Viatrac 14 Plus.; Abbott Xact Carotid Stent System.; Boston Scientific Emerge MR PTCA Dilatation cathet.; Cook Micropuncture Introducer set.; Cook Rosen wire.; EV3 Amplatz Goose Neck Snare kit (2).; Merit Medical Performa MCS.; Penumbra Neuron Max.; Stryker Synchro Select Standard straight.; Terumo Glidewire angled.; Terumo Pinnacle.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 140 LB
• Patient Race: White