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 07/30/2023

Event Type  malfunction  

Manufacturer Narrative

The proximal segment of the zoom 71 catheter was returned for investigation.Investigation demonstrated damage to the catheter shaft materials which suggests that an axial force was applied during the procedure, stretching the shaft materials prior to the device breaking.Investigation demonstrated stretched coil, and outer jacket at the break location.The distal segment was not returned.Based on the imaging provided, the distal segment was observed to have a deformed marker band and a stretched and tangled catheter jacket.The exact root cause for the broken shaft 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 Description

An 85-year-old female was treated for an occlusion in the internal carotid artery (ica) to the terminus.The patient's anatomy was noted to be extremely tortuous, and the occlusion was significant and dense.Access was obtained with 0.014" guidewire, third-party access catheter, and third-party microcatheter.The access catheter was advanced through three bends of ica tortuosity without issue and was positioned at the cavernous segment.A third party microcatheter was advanced to the ica.During the first pass, the zoom 71 aspiration catheter was advanced through the access catheter and over the microcatheter to the face of the clot in the ica.The treating physician reported the zoom 71 "felt tight" before the terminus of the ica.Aspiration was applied.Upon retraction multiple "large dense chunks" of clot were observed at the tip of the zoom 71.While removing the guidewire, microcatheter, and the zoom 71, the physician felt the zoom 71 get partially stuck in the anterior genu, near the carotid terminus adjacent to the ophthalmic.According to the physician, the distal portion of the zoom 71 had partially separated and became lodged in the rotating hemostatic valve (rhv).The physician believed the distal portion of the zoom 71 had separated within the access catheter.Both the zoom 71 catheter and the separated shaft were successfully removed with the rhv.The treating physician noted that the access catheter had become obstructed by the clot.The access catheter was retracted from the carotid to aspirate the dense, dark black clot.In the second pass, the same third-party access catheter was once again advanced into the tortuous ica.A third-party aspiration catheter was advanced to the clot located at the inferior m2 segment and aspiration was applied.The clot was removed successfully.The patient achieved partial reperfusion with a tici 2c score and was reported to be in stable condition.No patient sequelae were reported.

• 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: 17625082
• MDR Text Key: 321971148
• Report Number: 3014590708-2023-00026
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2312201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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: INFINITY GUIDE CATHETER; RED 68 ASPIRATION CATHETER; ROTATING HEMOSTATIC VALVE (RHV); SYNCHRO 0.014" GUIDEWIRE; VELOCITY MICROCATHETER
• Patient Age: 85 YR
• Patient Sex: Female