MAUDE Adverse Event Report: Imperative Care Inc. Zoom Catheter

Model Number	ICRC055137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: Zoom Catheter
• Common Device Name: Zoom Catheter
• 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: 50926368
• Report Number: 3014590708-2026-00034
• Device Sequence Number: 5851989
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: (01)00812212030474(17)290408(10)F2609701
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/28/2026

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: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2609701
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female