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 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint indicated material deformation of zoom 71 and resistance during advancement.The zoom 71 catheter was returned for investigation.The investigation confirmed severe damage to the distal portions of the catheter shaft including stretching, kinking, and separation of the shaft material.The catheter returned for investigation was in two segments.The separation of the catheter is attributed to handling of the device after the procedure while it was being returned for investigation.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 most likely root cause is retraction of the zoom 71 through a kinked guide catheter.

Event Description

A patient was treated for an occlusion at the m1 segment.Access was obtained with a tracstar access catheter over a guidewire.The tracstar was positioned at the ica (internal carotid artery).A zoom 71 was then advanced through the tracstar.The patient's anatomy was reported to be tortuous.An abnormal interaction/resistance was noted between the catheters.The zoom 71 was advanced to the location of the kink, as observed under fluoroscopy, in the tracstar.Upon removal of the zoom 71 from the patient, the outer jacket was separated exposing the coil of the zoom 71 catheter.The coil was still holding both segments of the catheter together.The tracstar was removed from the patient and the kink was confirmed.A replacement tracstar and zoom 71 catheter were used to complete the procedure successfully.The patient achieved complete reperfusion with a tici 3 score.There was no intervention performed and 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: 17233069
• MDR Text Key: 318313711
• Report Number: 3014590708-2023-00022
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2231201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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: SYNCHRO WIRE; TRACSTAR
• Patient Outcome(s): Other