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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An 85-year-old-male was treated for mechanical thrombectomy to remove an occlusion from the right m1 segment.The patient's anatomy was reportedly tortuous.Access was obtained using a third-party access catheter which was advanced to the first big turn in the tortuous loop in distal cervical ica.The zoom 71 was then advanced over a third-party guidewire and zoom 35 to the clot at the proximal m1 segment.The guidewire and zoom 35 catheter were removed.Aspiration was performed with the zoom 71 catheter.As the zoom 71 catheter was retracted under aspiration and the clot was removed.During the removal of the zoom 71 catheter, the physician felt resistance but kept pulling back the catheter.As the physician pulled back on the zoom 71, the catheter broke around 22cm from the distal tip of the catheter.A snare was used to retrieve the broken segment but was unsuccessful.A stent retriever was then used to retrieve the broken segment, however during the retrieval attempt only the distal 2 cm of the broken segment was able to be retrieved.The procedure was completed.A day or two later the patient was returned to the cath lab and the physician attempted to use aspiration and a stent retriever to remove the catheter but was unsuccessful, so he sacrificed the vessel with a plug and coils.No other patient sequelea were reported.
Additional Manufacturer Narrative
The zoom 71 was retained by the account and not returned for investigation.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Without the device return, the exact root cause for the shaft break could not be determined.Based on the limited case information provided, it was noted that resistance was felt during retraction of the zoom 71 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.".

• 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: joy patel ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 22199497
• Report Number: 3014590708-2025-00013
• Device Sequence Number: 17864318
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)280203(10)F2503101
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: F2503101
• 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: 05/15/2025
• Initial Report FDA Received Date: 06/12/2025
• Date Device Manufactured: 02/03/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENUMBRA BMX 96; TRAXCESS .014" WIRE; ZOOM 35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 86 KG