MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM 7X CATHETER

Model Number	ICRC07X137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A zoom 7x device and rhv were returned for investigation.The device was received without the distal tip, confirming distal tip/marker band separation.Examination of the returned device identified separation at the location where the marker band detached from the distal end of the catheter shaft.The separation location exhibited minimal stretching of the catheter materials.The catheter shaft exhibited no evidence of kinking, stretching, crushing, buckling, coating damage, or other mechanical damage.No damage was identified on the returned rhv.Based on the available information and evaluation of the returned device, a definitive root cause for the distal tip detachment could not be established.Examination confirmed the reported failure mode and indicated that separation occurred at the marker band/distal tip attachment interface.However, the specific mechanism that resulted in the separation could not be conclusively identified.Manufacturing records were reviewed and confirmed the product met all design and manufacturing specifications prior to release.
Event or Problem Description
It was reported that during a mechanical thrombectomy procedure targeting the internal carotid artery (ica), middle cerebral artery (mca), anterior cerebral artery (aca), and posterior communicating artery (pcom) territories, the distal tip (marker band separation) of a zoom 7x detached.The event occurred during the third pass, with the break occurring in the m1 segment.The physician reported encountering resistance while advancing the zoom 7x through highly tortuous segments of the ica and described the anatomy as having extreme tortuosity.Attempts to retrieve the detached marker band were made using a stent retriever and another zoom 7x; however, these attempts were unsuccessful.The detached marker band was subsequently pushed into the right anterior temporal artery by a zoom 35 catheter.The physician elected to leave the detached marker band in the right anterior temporal artery as it was reported to be non-flow limiting.Post-procedure, it was reported that the patient passed away on (b)(6) 2026.The patient had a do not resuscitate/do not intubate (dnr/dni) order in place and was subsequently transferred to hospice care, where compassionate extubation was performed.According to the treating physician, the patient's death was unrelated to the reported event of tip detachment.The physician attributed the patient's death to the severity of the infarct, describing it as a very large core stroke.The physician further stated that the clinical outcome was related to the size of the infarct and the rapid progression of the stroke, which was impacted by the patient's congestive heart failure (chf) and reduced ejection fraction.

• Brand Name: ZOOM 7X CATHETER
• Common Device Name: ZOOM 7X 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: 25588350
• Report Number: 3014590708-2026-00024
• Device Sequence Number: 10012744
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)270223(10)F2605001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K243047
• 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): 06/22/2026

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: ICRC07X137
• Device Catalogue Number: ICRC07X137
• Device Lot Number: F2605001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2026
• 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: ZOOM 35.; ZOOM 7X.; ZOOM 88 SUPPORT.; ZOOM 88.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White