MAUDE Adverse Event Report: IMPERATIVE CARE ZOOM REPERFUSION 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	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A zoom 55 was returned for investigation without the distal marker band tip.Investigation confirmed marker band detachment.Investigation of the returned device showed damage to the catheter near the distal tip of the device.The damage indicates an axial force was applied to the catheter which resulted in material separation and detachment of the radiopaque marker band from the catheter.The radiopaque marker band was not returned for investigation.The third-party sheath used in the case was not returned for evaluation.Based on the complaint information provided, the exact root cause for the reported complaint could not be determined.The manufacturing records for the zoom 55 were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
It was reported that the patient underwent a mechanical thrombectomy for treatment of an m2 segment clot.The physician was unable to access the femoral artery and decided to access radial artery using a third-party sheath.The physician was unable to reach the m2 clot with the zoom 55 and decided to exchange zoom 55 catheter under fluoroscopy for a zoom 45 reperfusion catheter.There was no friction or issues during the exchange of the two catheters reported.Upon advancement of the zoom 45 catheter into the m1 segment, a repeat fluoroscopic evaluation revealed the tip of zoom 55 in the a1 segment.Clot aspiration was successfully performed using the zoom 45 catheter.Subsequently, the physician removed the zoom 45 and exchanged the third-party sheath for a zoom rdl.A third-party stent retrieval device was then used to extract the zoom 55 tip, which was successfully retrieved without further complication.The procedure was completed without any patient sequelae.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: ZOOM REPERFUSION CATHETER
• Manufacturer (Section D): IMPERATIVE CARE; 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: 22536123
• Report Number: 3014590708-2025-00015
• Device Sequence Number: 7488126
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: (01)00812212030474(17)270808(10)F2421401
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/17/2025

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: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2421401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: PHENOM 27; SYNCHO 014; TERUMO 6X23; TIGER 13; ZOOM 45; ZOOM RDL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male