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

Model Number	IC-4593AE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.
Event or Problem Description
It was reported that on (b)(6) 2016 at 23:45 a zoll quattro catheter was placed successfully in the femoral vein.The patient was having a procedure in the cath lab.At the end of the procedure, the quattro catheter was disconnected from the start-up kit (suk) and both green (in and out) ports of the quattro catheter were connected and both ends of the suk tubing were reconnected to become a closed system again.The patient and ivtm system were transferred to the icu where the physician wanted to reconnect the green ports to the suk again.He opened the suk tubing but could not reconnect both ends to the appropriate green port of the quattro catheter.A new suk which was prepped according to the instructions and this one was connected to the quattro catheter without any issues.The physician believes that he put too much power during the closure of the suk tubes in the cath lab that the damages the luer lock system.On (b)(6) 2016 at 08:00, the quattro catheter was removed.After removal of the catheter from the femoral vein, minor bleeding was noted at the access site which was treated with superficial bandage.The bleeding was resolved without any sequelae.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5586087
• Report Number: 3010617000-2016-00275
• Device Sequence Number: 10826950
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0660
• Device Lot Number: 60774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2016
• Initial Report FDA Received Date: 04/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other