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

Model Number	SL-2593
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the catheter for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Event or Problem Description
The customer reported that the proximal securing device continues to dislodge off the solex 7 catheter, which causes the catheter to malposition resulting in leakage of intravascular fluid from proximal or medial infusion luers (as the catheters were no longer in the vessel).The customer stated that the reported issue could cause a risk of infection and the risk of infiltration of vasoactive fluids into sq (subcutaneous) space.The suture tab and clip provided in the catheter kit are not tight enough, allowing the catheter to slip out of the vessel.The catheter is not staying in place within the suture tab and clip.The customer stated that the reported issue had happened multiple times.No adverse reactions to the patient were noted.
Additional Manufacturer Narrative
The customer reported a complaint that "the solex 7 catheter (lot #184298) is not staying in place within the suture tab and clip" was not confirmed during the visual and functional testing of the returned catheter.No device malfunction or damage was found during the testing.The suture tab, clip, and returned catheter functioned as intended.A visual inspection was performed.The suture tab and clip were returned along with the catheter and were not attached to the catheter shaft as received.No issues or discrepancies were found.No physical damage on the catheter was noted.Observed dried blood had accumulated on the suture tab and clip.Functional testing was performed.The suture tab and clip can be attached to the catheter shaft, and no problem was found.They are tight enough to hold the catheter in place.The catheter stayed in place and did not slip out of the suture tab and clip.A functional pressure leak test was performed.All infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi, and no leaks were observed.The balloons did not leak during inflation and deflation.The catheter functioned as intended.

• Brand Name: ZOLL IVTM SOLEX 7 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: 16889235
• Report Number: 3010617000-2023-00444
• Device Sequence Number: 12305516
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/08/2023

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: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 184298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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 Sex: Unknown