MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM ICY CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-3893
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Zoll received medwatch report #(b)(4) on (b)(6) 2023 for the event reported below: the icy catheter (lot # unknown) was utilized in ivtm therapy for a 44-year-old female patient.The patient was taken for a computed tomography (ct) scan.During contrast administration, a hole formed in the distal lumen of the catheter.The customer reported device failed but did not provide further information.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll did not receive the catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
Zoll received medwatch report # (b)(4) on 08 august 2023 for the event reported below: the icy catheter (lot # unknown) was utilized in ivtm therapy for a 44-year-old female patient.The patient was taken for a computed tomography (ct) scan.During contrast administration, a hole formed in the distal lumen of the catheter.Upon follow-up, the customer mentioned a power injector was used to administer the contrast agent.The customer reported that the device failed but did not provide further information.No consequences or impacts on the patient.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated based on the received additional information.H6 (health effect - clinical code) was updated based on the received additional information.H6 (health effect - impact code) was updated based on the received additional information.H6 (type of investigation) was updated based on the received additional information.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17671224
• Report Number: 3010617000-2023-00742
• Device Sequence Number: 20605019
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female