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 01/10/2024

Event Type  Injury  

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 during the procedure, 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.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.The most probable cause of the zoom 71 shaft breakage is retraction of the zoom 71 through a known kinked zoom 88 support guide catheter.

Event Description

A 73-year-old female was treated for an occlusion in the superior sagittal sinus (sss) vein.Access obtained at the left internal jugular.A guidewire, a third-party catheter, and a zoom 88 support access catheter were advanced to the sss.The third-party catheter was then replaced by a zoom 71 catheter.Once at the sss, the treating physician attempted to advance the zoom 88 support higher into the sss but was unsuccessful due to a tortuous jugular vein.A reported kink was observed just proximal to the distal segment on the zoom 88 support.The first pass was completed with the zoom 71, utilizing syringe for aspiration.During the second pass, the physician continued the procedure using the same kinked zoom 88 support.Two different guidewires were used by the physician to straighten out and reduce the kink of the zoom 88 support, allowing the zoom 71 to be advanced to the sss clot.During retraction, the physician was unable to remove the zoom 71.He noticed under fluoroscopy the distal portion stretching and the tip of the zoom 71 was not moving.The physician then advanced the guidewire into the lumen of the zoom 71 to the tip and removed the devices from the patient as a system.For the third pass, a new catheter system (third-party guide catheter and third-party aspiration catheter) was used to successfully complete the procedure.The patient is reported to be stable without any sequelae.

• 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: 18700239
• MDR Text Key: 335295588
• Report Number: 3014590708-2024-00002
• Device Sequence Number: 1
• Product Code: NRY
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2325102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2023
• 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: 035 GLIDEWIRE (TERUMO); 035 STORQ GUIDE WIRE (CORDIS); 8F SHEATH; PENUMBRA BERENSTEIN-SHAPED SELECT CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 85 KG