MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 7 CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-4593
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed when the product is returned and investigation has been completed.
Event or Problem Description
As reported, during patient ivtm therapy, the user facility nurse noticed less than 100cc left in saline bag within the last hour.No fluid on the floor, around machine or in patient's bed was observed.The solex 7 catheter (ln unknown) was removed and replaced with a new catheter to continue with the therapy.No consequence to patient was reported.
Additional Manufacturer Narrative
The reported complaint of a solex 7 catheter leak was confirmed during function testing.A pinhole leak was found at the middle of serpentine balloon.No physical damaged observed on the returned catheter during visual inspection.Blood had accumulated on the serpentine balloon.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.In addition, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at the middle of serpentine balloon.Thus, confirming the reported 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.The investigation findings determined that the probable cause of the reported issue was due to a latent material defect.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for solex 7 catheter with lot number 73568.

• Brand Name: ZOLL IVTM SOLEX 7 CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7928309
• Report Number: 3010617000-2018-00992
• Device Sequence Number: 16622798
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: IC-4593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 73568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1