MAUDE Adverse Event Report: ZOLL CIRCULATION INC ZOLL IVTM SOLEX 7 CATHETER; CENTRAL VENOUS CATHETER

Model Number	SL-2593
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned by the customer.Therefore, an investigation cannot be completed.Per the solex catheter ifu, the solex catheter should be placed via a jugular vein approach only.The patient was be seen by the vascular surgery team for removal because a closure device to stop bleeding was placed, which is normal for removal of a catheter from an artery.During the removal, no difficulty was reported.Event assessed as serious because surgical intervention was required to remove the catheter.Based on the available information, the event was probably related to the zoll catheter due to the fact that the catheter required intervention for removal.The event is probably related to the device and not related to the procedure.
Event or Problem Description
The customer reported that they incorrectly placed the solex catheter (lot unknown) into an artery of a male patient.Per the solex catheter ifu, the solex catheter should be placed via a jugular vein approach only.The issue was immediately noticed during the x-ray before the start of therapy, which is required to ensure proper placement of the catheter.The physician said the patient will be seen by the vascular surgery team for removal because a closure device to stop bleeding will be placed, which is normal for removal of a catheter from an artery.During the removal, no difficulty was reported.Ivtm therapy was started and completed using a different catheter.The patient was not injured.

• Brand Name: ZOLL IVTM SOLEX 7 CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16903254
• Report Number: 3010617000-2023-00408
• Device Sequence Number: 14843219
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K081936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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 Model Number: SL-2593
• Device Catalogue Number: 8700-0671-01
• 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: 04/11/2023
• Initial Report FDA Received Date: 05/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male