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

Model Number	ICRC071137
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient required an acute stroke intervention secondary to an occlusion in the left proximal basilar artery.During the procedure, a minute catheter tip fragment was embedded in the left pca.Clinical decision was made to not remove the fragment.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE, INC.
• MDR Report Key: 12871283
• Report Number: 12871283
• Device Sequence Number: 5748747
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: (01)00812212030191
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2021
• Report Date (Section F): 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2126501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2021
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/24/2021