MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM REPERFUSION CATHETER

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 37-year-old female patient was undergoing a mechanical thrombectomy to remove an occlusion at the right m1 segment.Access was obtained using a zoom tracstar access catheter.A zoom 71 catheter was advanced through the access catheter over a third-party guidewire to the face of the clot.The first pass aspiration was completed without any issues.On the second pass the physician felt resistance as he began to retract the zoom 71 catheter.The zoom 71 catheter broke approximately 8-10 cm from tip.The broken catheter piece was retrieved with a third-party microcatheter and stent retriever.The patient was then stented in the m1 segment due to a vessel dissection that was unrelated to the zoom catheters.The patient was reported to be doing well.Several attempts were made to obtain additional information but were unsuccessful.
Additional Manufacturer Narrative
The zoom 71 was returned separated into distal and proximal catheter segments.Device investigation noted damage which suggests an axial force was applied during the procedure resulting in stretching of shaft materials prior to the device breaking.Kink damage was observed on each zoom 71 catheter segment and tip damage was observed on the distal segment.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.The exact root cause for the shaft break could not be determined from the device investigation.Based on the limited case information provided, it was noted that resistance was felt during the second pass while aspirating the clot.The zoom ifu provides the following warning related to 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.".
Additional Manufacturer Narrative
Correcting selection d7a from "yes" to "no".

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: ZOOM REPERFUSION CATHETER
• Manufacturer (Section D): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer Contact: katharine treangen ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 22146514
• Report Number: 3014590708-2025-00012
• Device Sequence Number: 7639203
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)280121(10)F2501701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2501701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 01/21/2025
• 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: .35 COLLASAS WIRE FROM SCIENTIA; TRAK 21 MICROCATHETER; TREVO STENT RETRIEVER; ZOOM 35; ZOOM TRACSTAR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female