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

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	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The proximal segment of the zoom 71 catheter was returned for investigation.Investigation confirmed that shaft breakage that occurred and suggested that an axial force was applied during the procedure, stretching the shaft materials prior to breaking.Based on the complaint investigation, limited case images and no return of adjunctive device, the exact root cause could not be determined.However, based on the event description, evidence suggests that a tortuous anatomy and retraction of the zoom 71 against resistance were potential factors that contributed to the reported shaft break.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
An 85-year-old patient was treated for an occlusion at the left middle cerebral artery (mca).Access was obtained using a zoom 88 access catheter, which was advanced to the high cervical.The physician noted a kink in the access catheter, due to a 360-degree loop at the iliac.The physician straightened out the kink.During the first pass, a zoom 71 aspiration catheter was advanced through the zoom 88 to the clot in the left mca.The physician confirmed there was no resistance while advancing the catheter.After the zoom 71 corked the clot, aspiration was applied, and the clot was removed after the first pass.The patient achieved complete reperfusion with a tici 3 score.While retracting the zoom 71 through the zoom 88, resistance was noted.The physician indicated the arch was "challenging" and the patient had a tortuous anatomy.Imaging showed that the zoom 71 had separated approximately 10-12 cm from the distal portion of the catheter in the internal carotid artery and drifted into the left m1 segment.A microcatheter and stent retriever were advanced through the zoom 88 to the broken zoom 71 segment.The stent retriever successfully captured the zoom 71 segment and was retracted into the zoom 88 access catheter.The broken segment, microcatheter, stent retriever and the zoom 88 were removed from the patient as a system.The patient was reported stable, and no patient sequelae were reported.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC.; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell; campbell, CA 95008-6609
• MDR Report Key: 20070918
• Report Number: 3014590708-2024-00029
• Device Sequence Number: 7784870
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/26/2024

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 Expiration Date: 04/23/2026
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2404502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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: BRITE TIP LONG SHEATH 8F X 45CM; EMBOTRAP; SYNCHRO2 WIRE; ZOOM 88 110CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Unknown