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

Model Number	CL-2295
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll coolline catheter for investigation.A supplemental report will be filed when the product is returned and investigation has been completed.
Event or Problem Description
During hypothermia therapy, the coolline catheter was observed with blood on the catheter tubing.The nurse reported a "balloon rupture" on the catheter.No further patient information received.No known impact or patient consequence information was available.
Additional Manufacturer Narrative
The reported complaint of a leaking cool line catheter (lot #81103) was confirmed during functional testing.A pinhole leak was observed at distal end of proximal balloon.The probable root cause for the reported complaint can be a latent material defect.Visual inspection of the returned cool line catheter was performed and observed no physical damage.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The returned catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed.Thus, confirming the reported complaint.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 service information related to the reported complaint and there was no history of complaint reported for cool line catheter with lot number 81103.

• Brand Name: ZOLL IVTM COOLLINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8308565
• Report Number: 3010617000-2019-00114
• Device Sequence Number: 1634682
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: CL-2295
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: 81103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1