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 Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoom 71 catheter was returned for investigation.Investigation confirmed marker band detachment.Investigation of the returned device showed significant damage to the materials of the distal section of the catheter near the tip including stretching and tearing.The damage indicates an axial force was applied to the catheter which resulted in the material separation and detachment of the radiopaque marker band from the catheter.The radiopaque marker band was not returned for investigation.The zoom 88 catheter was also not returned for investigation.Based on the provided complaint information, review of the case images, and without the return of adjunctive access catheter, the exact root cause could not be determined.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 83-year-old male 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 mid cervical.During the first pass, a zoom 71 aspiration catheter was advanced through zoom 88 to the clot in the left mca.Aspiration was then applied to the zoom 71.The zoom 71 was retracted into zoom 88 and resistance was noted when the tip of zoom 71 reached the tip of zoom 88.The treating physician continued removal of the zoom 71 through the zoom 88.After the zoom 71 removal, it was noted that the radiopaque marker band was missing.Imaging was conducted and showed the zoom 71 marker band remaining in the patient.The physician determined that the marker band was non-flow limiting and decided to not attempt removal.The zoom 88 was removed from the patient.No device deficiency was observed on the zoom 88.A new catheter system consisting of a third-party guide catheter, a third-party aspiration catheter, and a zoom 35 was used to complete the procedure.The clot was removed with the zoom 35 catheter.The patient achieved complete reperfusion with a tici 3 score and is reported to be stable.There were no other patient sequelae 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: 19778657
• Report Number: 3014590708-2024-00024
• Device Sequence Number: 8269102
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/18/2024

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: 02/13/2026
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2334201
• 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: 06/20/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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: ARISTOTLE 0.018" WIRE.; PENUMBRA BMX 96 90CM.; PENUMBRA SELECT 6F SIM.; RED 72.; STRYKER SYNCRO SELECT 0.014" WIRE.; ZOOM 35.; ZOOM 88.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male