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 05/29/2022

Event Type  malfunction  

Manufacturer Narrative

The zoom 71 catheter was returned for investigation.Device investigation confirmed shaft breakage at approximately 16cm from the distal end of the catheter.Based on the limited information provided and lack of case images, the exact root cause of shaft breakage is unknown.The tortuous anatomy could have created a constricted path for the zoom 71 which potentially contributed to the shaft breakage.The manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed prior to release to ensure the device met specifications.

Event Description

The patient was undergoing a thrombectomy procedure to treat an occlusion in the right internal carotid artery (ica) m1 segment.The patient reportedly had a tortuous anatomy.Access was obtained radially with tracstar and zoom 71.After one pass, tici 3 was achieved.Upon removal, zoom 71 was noted not to be fully intact.The catheter had broken approximately 10 cm from the distal end.The physician did not see bleed back out of tracstar, so he applied suction and the distal segment came out.After multiple communication attempts with the account, no other information could be obtained.No patient consequences 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 avenue; campbell, CA 95008-6609
• MDR Report Key: 14918889
• MDR Text Key: 303420960
• Report Number: 3014590708-2022-00014
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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: TRACSTAR