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	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was treated for an occlusion at the right distal m1 segment.Access was obtained using a guidewire, a zoom 88 access catheter, and a third-party select catheter.The physician noted a tortuous arch anatomy but no stenosis or calcification.During the first pass, the zoom 88 was parked at the distal cervical.A zoom 71 catheter was then advanced over the select catheter and through the zoom 88 to the face of the clot.After removing the guidewire and third-party select catheter, aspiration was applied to the zoom 71.The zoom 71 was removed without any reported issue.Post contrast run, an angiogram imaging showed the clot was not completely removed.For the second pass, the same zoom 71 was advanced through the zoom 88 and aspiration began.The zoom 71 was removed without any resistance.After the contrast run, imaging showed that the distal portion (approximately 1 cm) of the zoom 71 catheter was sitting in the right middle cerebral artery.The physician attempted to remove the separated distal catheter portion with an 0.024" guidewire, however, without success.The physician decided to advance a second zoom 71 through the zoom 88 and successfully aspirated the separated piece of the first zoom 71.The physician performed a final angiogram and determined full reperfusion with a tici 3 score.No patient sequelae were reported.The patient was discharged home and is doing well.
Additional Manufacturer Narrative
The zoom 71 catheter was returned for investigation.Investigation confirmed the reported shaft breakage that occurred and suggested that an axial force was applied, stretching the shaft materials prior to breaking.Investigation demonstrated stretching and kinking along both the distal and proximal segments of the broken catheter shaft.Stretched catheter jacket materials were observed on both the distal and proximal segments of the zoom 71.Based on the provided complaint information, review of the case images and without the return of the competitor's adjunctive device, 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.

• 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: 19272064
• Report Number: 3014590708-2024-00018
• Device Sequence Number: 7034530
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/08/2024

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: 11/07/2024
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2330701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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 0.024"; ZOOM 35; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown