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

Model Number SL-2593AE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  Death  

Manufacturer Narrative

The solex 7 catheter associated with this complaint was not returned for evaluation.The customer disposed the catheter.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.Per reporter, the insertion with the solex 7 catheter was smooth and it was only placed 16cm mark in the patient internal jugular vein.Catheter dwell time was 6 days.During ivtm therapy, customer noticed increased swelling on the patient's neck area.Patient ct scan showed mild subcutaneous air in neck area and patient developed swelled tounge after post ct scan.Patient has no documented allergies.Reported believes there was no harm to the patient attributed to zoll catheter.Additional information requested.

Event Description

During ivtm therapy, the customer noticed increased swelling on the patient's neck area.Patient ct scan showed mild subcutaneous air in the neck area and patient developed swelled tongue after the post-ct scan.The patient has no documented allergies.Per a reporter, the insertion with the solex 7 catheter (lot #unknown) was smooth and it was only placed at 16 cm mark in the patient internal jugular vein.Treatment was completed successfully and catheter dwell time was 6 days.Patient expired.As per the customer, the patient's death was not related to the solex catheter.

Manufacturer Narrative

Correction: the initial mdr was documented as "the customer disposed the catheter", however, a solex 7 catheter (lot#: 157518) was returned for investigation.Also, the initial mdr, section h6; clinical code 4582 "no clinical signs symptom or conditions" was inadvertently selected.The reported complaint of the customer noticed increased swelling on the patient's neck area during the use of solex 7 catheter was returned for investigation.During the findings, no leak or damage observed during testing and visual inspection of the catheter.No malfunction on the catheter was observed.The catheter performed as intended.During visual inspection, no physical damage was observed on the catheter.All lumens were flushed without resistance.Pressure leak test: the catheter was connected to a pressurized inflation device, the balloons fully inflated when pressurized up to 100 psi without any issues.No leak was found, the catheter performed as intended.An additional functional test was performed.The returned catheter was connected to the known good suk and ran on a peristaltic pump for 10 minutes at a high speed rate and also run on the console system in both warming and cooling mode for a total of 2hrs.No leak was observed on the catheter.The catheter performed as intended.Zoll investigational results confirmed that the reported problem was not confirmed.No leak and no damage was found during testing.

• Brand Name: ZOLL IVTM SOLEX 7 CATHETER
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11853876
• MDR Text Key: 251638878
• Report Number: 3010617000-2021-00404
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (y/n): N
• PMA/PMN Number: K101987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 157518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death