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

Model Number	CL-2295
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A female patient was hospitalized post cardiac arrest and underwent treatment for hypothermia.At the start of the therapy.Upon starting the cooling, blood was noted in the startup kit (suk) and air trap alarm went off.The saline bag was observed to be empty.The cool line catheter was replaced and the therapy was reinitialized.No patient consequences were reported.
Additional Manufacturer Narrative
On (b)(6) 2017, the customer filed a voluntary event report (report number: mw5069558) regarding the cool line catheter with lot number: 62191.The event report was found to be associated with this mdr submission (mfr.Report number: 3010617000-2017-00343).The customer reported there was no adverse event; however, due to the reported malfunction, intervention was required.
Additional Manufacturer Narrative
A cool line catheter (lot # 61118) was returned to zoll (b)(4) for evaluation.Evaluation of the returned catheter confirmed the customer reported complaint as a coolline catheter pinhole leak at the distal end of the proximal balloon.During manufacturing all coolline catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes for the reported complaint can be a latent material defect or the balloon may have seen higher stress during insertion.Visual inspection found no visual discrepancies or issues.All lumens flushed as intended.The returned catheter was connected to a pressurized inflation device.A pinhole leak was observed when the pressure was increased up to 10psi.The leak was noted at the distal end of the proximal balloon.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for coolline catheter lot # 61118.

• 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: 6549436
• Report Number: 3010617000-2017-00343
• Device Sequence Number: 97220
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2017

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: 8700-0781-01
• Device Lot Number: 61118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 06/09/2017; 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1