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

Model Number	SL-2593
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported problem of "the customer experienced difficulty while advancing the solex 7 (lot #172347)" was confirmed during the visual and functional testing of the returned catheter.A kink on the shaft was observed in the middle of the serpentine balloon (4 cm away from the catheter tip).The exact timing and cause of the kink on the catheter cannot be determined, but user handling or insertion of the catheter could not be ruled out.Visual inspection was performed and found the catheter shaft was kinked in the middle of the serpentine balloon (4 cm away from the catheter tip).No other physical damage was observed on the catheter.Observed blood residues on the serpentine balloons.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi without any issues.No leak was found during testing.An additional guidewire test was performed: a known-good zoll guidewire was slowly inserted through the central lumen of the catheter, starting at the catheter tip, the guidewire got stuck at 4 cm away from the catheter tip due to the kink on the shaft, thus confirming the reported problem.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint, and there were no similar complaints reported for the solex catheter with lot number 172347.
Event or Problem Description
During the solex 7 (lot # 172347) catheter placement for an ivtm therapy, the customer experienced difficulty while advancing the catheter.Per the nursing staff, the physician did not use an introducer during the catheter placement.A second catheter was successfully placed in the same location to continue ivtm therapy.No consequences or impact to patient.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17096086
• Report Number: 3010617000-2023-00498
• Device Sequence Number: 1988737
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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): 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: 172347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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