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

Model Number	601252-001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The icy catheter (lot no.85938) was returned to zoll on 06/10/2019 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
An icy catheter was inserted into the patient and approximately after 2 hours of ivtm therapy, the user observed decreasing saline volume in the saline bag (about 200 ml).No leak was noted on the start-up kit (suk), suspecting catheter leak.Following this, the physician discontinued ivtm therapy and removed the catheter.Adjunct therapy was performed.No known impact or patient consequence was provided.
Additional Manufacturer Narrative
The reported complaint of icy catheter (lot# 85938) leak was confirmed.A pinhole leak on the shaft was observed at 1cm away from the distal end of manifold during functional leak test.Probable causes for the reported complaint can be a latent material defect.Visual examination of the returned catheter was performed and no evident physical damage was observed on the catheter.Observed blood residues on the balloons and on the tubing ports.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance, except the medial and proximal ports were clogged with blood.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak on the shaft was observed at 1cm away from the distal end of manifold.The catheter was inspected under the microscope to confirm the pinhole noted during functional test, thus confirming customer 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 information related to the reported complaint and there was no previous history of complaint reported for a catheter with lot number 85938.

• 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: 8687257
• Report Number: 3010617000-2019-00485
• Device Sequence Number: 2511128
• Product Code: NCX
• UDI-Device Identifier: 00849111050043
• UDI-Public: 00849111050043
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 601252-001
• Device Catalogue Number: 8700-0657-03
• Device Lot Number: 85938
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1