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

Model Number	SL-2593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter associated with this complaint was not returned for evaluation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During ivtm therapy, a zoll catheter (lot# unknown) was inserted into the patient's femoral vein.At the end of the therapy, the blood was noted in the catheter tubing, and the catheter leak was suspected.The catheter was removed as the patient was done with the treatment.No consequences or impact to the patient.Per the reporter, it is unknown what model of zoll catheter was used during the reported event.
Event or Problem Description
During ivtm therapy, a solex 7 catheter (lot # 195141) was inserted into the patient's femoral vein.At the end of the therapy, the blood was noted in the catheter tubing, and the catheter leak was suspected.The catheter was removed as the patient was done with the treatment.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of the solex 7 catheter (lot # 195141) leak was confirmed during the functional testing.A pinhole leak was observed at the proximal end of the serpentine balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.A visual examination of the returned catheter was performed, and no physical damage was found on the catheter.Noticed dried blood residues on the catheter's serpentine balloon and luered tubings.A functional leak test of the returned catheter was performed, and all infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device during the functional pressure leak test.Upon pressurizing the catheter up to 100 psi, a pinhole leak was observed at the proximal end of the serpentine balloon, thus confirming the reported complaint.Pressurized functional testing could not be performed due to the pinhole leak discovered during the in/out lumen test.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 following process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for the solex catheter with lot number 195141.Catheter information was updated.

• 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 sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18919226
• Report Number: 3010617000-2024-00236
• Device Sequence Number: 6476557
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2024

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: 195141
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 03/17/2024
• Supplement Report FDA Received Date: 04/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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