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

Model Number ICRC071137

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  Injury  

Event Description

A female patient was found to have a vessel occlusion at the left middle cerebral artery (mca).A competitor access guide catheter was positioned at the left cervical carotid.A zoom 71 and a competitor aspiration catheter were advanced towards the clot.The physician noticed a kink with both the zoom 71 and competitor aspiration catheters and removed both from the patient.A second zoom 71 catheter was inserted into the access guide catheter up to the clot and aspiration was performed.The physician experienced a high level of resistance while retracting the zoom 71 through the access guide catheter.Imaging showed the zoom 71 broke, leaving the distal portion of the catheter in the left internal carotid artery.The broken segment of the zoom 71 was successfully removed using a microsnare.Consequently, the physician believed there was a kink in the competitor access guide catheter.After identifying an additional clot in the mca, the competitor access guide catheter was replaced with a zoom 88 catheter.A stent retriever over a competitor microcatheter was used to remove the clot.The patient's anatomy was noted to be tortuous.A final tici 2b score was achieved.There were no patient sequelae reported.

Manufacturer Narrative

The proximal segment of the zoom 71 catheter was returned for investigation and the distal catheter shaft segment was not returned for investigation.Investigation confirmed the reported shaft breakage and suggested that an axial force had been applied to the catheter as it was passed through an access guide catheter with a kink.The proximal segment had stretched shaft materials at the location of the break.Photos provided of the distal segment also showed stretched shaft materials at the location of the break as well as several kinks along its length.The manufacturing records for the zoom 71 catheter were reviewed, and demonstrated the product met all the design and manufacturing specifications.Based on the information provided and device investigation, the exact root cause could not be determined.

• Brand Name: ZOOM REPERFUSION CATHETER
• Type of Device: 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: 16773725
• MDR Text Key: 313629746
• Report Number: 3014590708-2023-00008
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2232101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NEURON MAX GUIDE CATHETER; PENMBRA 3MAX REPERFUSION CATHETER; PENUMBRA 3D STENT RETRIEVER; SOLITAIRE STENT RETRIEVER; VELOCITY MICRO CATHETER; ZOOM 88 CATHETER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female