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  

Manufacturer Narrative

The zoom 71 catheter was returned for investigation.Investigation confirmed the reported shaft breakage and suggested that an axial force was applied during the procedure, stretching the shaft materials prior to breaking.Investigation identified stretching and kinking along the distal segment of the broken catheter shaft.The proximal segment of the zoom 71 catheter shaft was observed to have a section of stretched outer jacket at the break location.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Based on the complaint information provided and device investigation the exact root cause could not be determined.

Event Description

62-year-old male was undergoing a thrombectomy procedure to treat a large vessel occlusion at the left middle cerebral artery (mca).Access of the left mca was obtained with a competitor access catheter.A zoom 71 catheter was advanced to the clot and aspiration was performed.During removal of zoom 71, part of the clot broke and embolized into the left a1 and a2 segments of the anterior cerebral artery.A second pass was performed with the same zoom 71, competitor's microcatheter, and stent retriever.The zoom 71 was positioned in the supraclinoid/cavernous segment, while the microcatheter and stent retriever were advanced to the a2 segment.The stent retriever and microcatheter were then removed from the zoom 71 with the clot.An additional clot was observed in the m1/m2 segment.Under aspiration, a third pass was made with the same zoom 71 catheter.During retraction, the zoom 71 broke leaving approximately 27cm of the catheter in the internal carotid artery (ica).The distal portion of the zoom 71 was successfully removed via a contralateral femoral artery puncture using a pigtail catheter and a microsnare.The physician made multiple unsuccessful attempts to remove the additional clot through the initial femoral access with a competitor aspiration catheter and another stent retriever.A final tici 2b score was achieved.There were no patient sequelae 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: 16773514
• MDR Text Key: 313630253
• Report Number: 3014590708-2023-00009
• 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: 01/19/2024
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2301701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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: EMBOTRAP STENT RETRIEVER; MARKSMAN MICROCATHETER; MICROSNARE; NEURONMAX ACCESS CATHETER; PIGTAIL CATHETER; RED 62 ASPIRATION CATHETER; RED 68 ASPIRATION CATHETER; SOLITAIRE STENT RETRIEVER
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male