MAUDE Adverse Event Report: IMPERATIVE CARE, INC. ZOOM 71 REPERFUSION CATHETER ASPIRATION CATHETER; CATHETER, THROMBUS RETRIEVER

Catalog Number ICRC071137

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/30/2021

Event Type  malfunction  

Event Description

Patient with complete mid-basilar artery occlusion due to severe calcified atherosclerotic disease was undergoing thrombectomy.During the procedure, the tip of zoom 71 reperfusion catheter tip detached and remained retained even after multiple attempts made to retrieve.

• Brand Name: ZOOM 71 REPERFUSION CATHETER ASPIRATION CATHETER
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE, INC.; campbell CA
• MDR Report Key: 11776701
• MDR Text Key: 249433340
• Report Number: MW5101166
• Device Sequence Number: 1
• Product Code: NRY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2104102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 82