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

Model Number	8700-0660-01
Medical Device Problem Codes	Leak/Splash (1354); Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The icy catheter lot# 77255 was returned for evaluation.Visual inspection of the returned catheter lot # 77255 was performed.No abnormalities with the catheter were seen.All lumens flushed as intended.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pin hole leak was observed medial to the distal balloon.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 for related complaint to icy catheter lot# 77255, no previous history of complaint was identified.
Event or Problem Description
The nurse reported that approximately 6 to 7 hours into the ivtm treatment (patient cooling), evidence of leak was observed on the floor and a tinge of blood was observed on the start-up kit (suk) tubing suspecting leak on the icy catheter.No alarm was observed on the console.Following this, the console was placed on standby and 2nd icy catheter lot #77255 was inserted to complete the patient treatment.No known impact or patient consequence was reported.Relates to mfr 3010617000-2018-00159 1st icy catheter.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 7423377
• Report Number: 3010617000-2018-00429
• Device Sequence Number: 16155432
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 04/11/2018

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: 8700-0660-01
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 77255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1