MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM COOL LINE CATHETER; CENTRAL VENOUS CATHETER

Model Number	8700-0654
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint was returned to zoll on 04/13/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Note: the catheter was inserted for 6 days, which exceeds the maximum use period of 4 days per zoll's instructions for use.
Event or Problem Description
It was reported that during patient use with the cool line catheter a possible leak was observed.A male patient was hospitalized and required therapeutic treatment for fever management.A cool line catheter was placed in the right subclavian.The insertion was smooth and was performed by an experienced physician in one attempt.After 6 days of dwell time the nurse noticed the insertion site of the patient to be swollen and puffy (signs of infiltration).It was noted that the saline bag was empty.There was no evidence outside the patient of any fluid.The catheter was removed and the swollen site was treated with a dressing placed over the site.Another catheter was placed for a central line.It was later reported, after the event, the insertion site swelling had gone down at the insertion site.There was no patient sequelae reported.No additional information was provided.
Additional Manufacturer Narrative
A cool line catheter (s/n (b)(4)) was returned to zoll (b)(4) on 04/13/2016 for evaluation.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing.The returned catheter was connected to a pressurized inflation device.A pinhole leak was noted at the proximal end of the proximal balloon immediately after pressurizing the catheter.Following the test, all balloons deflated successfully without any issues.Device history record was reviewed for balloon bonding lot no 57635 found no nonconformities with the lot.Evaluation of the returned devices confirmed the customer reported issue as a cool line catheter pinhole leak at the proximal balloon.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5639021
• Report Number: 3010617000-2016-00316
• Device Sequence Number: 522783
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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: 8700-0654
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 06/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1