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	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An icy catheter (lot # 69965) was returned to zoll (b)(4) for evaluation.The customer reported complain for icy catheter leak was confirmed during functional testing.The root cause was due to a pinhole leak.Note, during manufacturing, all icy catheters are 100% inspected for leaks.In addition, extension tubing's are also 100% tested for leaks.Only units that pass the testing are moved to the next process.Thus, it is probable that a latent material defect in the balloon that could not be detected with our 100% leak testing.A visual inspection of the returned catheter was performed.Very minimum blood was noted on the shaft and manifold.No abnormalities with the catheter was seen.All infusion ports flushed successfully.During functional testing, the returned catheter was connected to a pressurized inflation device and pressure was increased up to 100 psi.Immediately upon pressurization, a pinhole leak was noted at the proximal end of the medial balloon.Following the test, all balloons deflated successfully without any issues.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for icy catheter sn (b)(4).
Event or Problem Description
A male patient was hospitalized post cardiac arrest.A zoll catheter was inserted into the left femoral vein by an experienced physician on (b)(6) 2017.During warming phase, on (b)(6) 2017, the saline bag was found to be empty.The catheter was removed and the patient was not able to complete the ivtm temperature management therapy.No known patient consequences reported.No other information was provided.

• 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: 6552484
• Report Number: 3010617000-2017-00345
• Device Sequence Number: 13769847
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

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: 8700-0695-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1