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

Model Number	8700-0654-01
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A cool line catheter (s/n (b)(4)) was returned to zoll (b)(4) for investigation.A visual evaluation of returned catheter was performed and found traces of blood on the shaft and infusion ports.The catheter was examined and there was no soft tissue observed at the tip of catheter.No balloon tear, balloon bond detachment; or rupture noted.All infusion ports flushed successfully with no issues observed.Functional testing of returned catheter was performed.When the catheter was connected to a pressurized inflation device; the balloons fully inflated when pressurized without losing pressure.The balloons did not leak during inflation and deflation.There were no difficulties during deflation of the catheter.No additional discrepancies or issues were observed.Device history record was reviewed for balloon bonding lot no 55520 found no nonconformities with the lot.Evaluation of returned cool line catheter indicated that the returned catheter performed as per specifications.Balloons were able to inflate and deflate without difficulties.Note, all cool line catheters are 100% inspected for leaks (pressure testing per mpi02-032).
Event or Problem Description
It was reported that a (b)(6) patient was hospitalized with a head trauma.The reason for ivtm therapy was for fever management.A cool line catheter was inserted in right internal jugular vein.The dwell time for the catheter was 5 days.During removal the physician experienced difficulty and could not remove the catheter.According to the physician in charge, it was possible to pull the cool line out up to the location of the proximal balloon, but resistance was felt after that point.Echo findings showed something white at the distal balloon.It appeared that some soft tissue or the like was snagged.A surgical procedure was requested of a cardiovascular surgeon.An incision was made at the location of the catheter insertion, and the catheter was removed by pulling soft tissue apart using kelly clamps.The presence of tissue on the removed catheter was not confirmed.The physician in charge did not think that this case involves a malfunction of the device, such as a catheter breakage.The physician speculated the reason why the catheter could not be removed smoothly, and said that soft tissue might have been stuck due to a structural issue of the device, such as the unevenness at the attachment part where the catheter shaft meets the balloon, hardness, etc.

• 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: 5601133
• Report Number: 3010617000-2016-00284
• Device Sequence Number: 11010009
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8700-0654-01
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: 55520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 04/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR