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

Model Number	IC-3893AE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on (b)(6) 2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
As reported, 24 hours after the icy catheter (lot number: 73032) was inserted into a patient's left femoral, blood was observed in the lumen of the start-up kit.The healthcare team believes there are leaks in the balloons, thus causing saline to be lost in the suk.Subsequently, an air trap alarm occurred.The catheter was ultimately replaced.Following the replacement, the patient was able to continue and complete their temperature management therapy.Per reporter, there was no patient injury as a result of the reported issue.
Additional Manufacturer Narrative
The customer reported complaint for a leak was confirmed during initial functional testing.A pinhole leak was noted 1.40 inches away from the tip.Evaluation of the returned icy catheter indicated that the catheter performed as per specification.A visual inspection of the returned catheter was performed and no abnormalities with the catheter was seen.All infusion ports flushed successfully.During manufacturing all icy 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.Historical complaints were reviewed and one previous complaint was reported for icy catheter (lot # 73032) for blood found in the start-up kit, under ccr 32188 reported on 14 aug 2017.The customer reported complaint was confirmed.A pinhole leak was noted at the medial balloon.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6827141
• Report Number: 3010617000-2017-00732
• Device Sequence Number: 1228661
• Product Code: NCX
• UDI-Device Identifier: 00849111075107
• UDI-Public: 00849111075107
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/13/2017

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: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 73032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1