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

Catalog Number	8700-0791-01
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A quattro catheter was placed into the artery in right groin.At night, the patient's right leg was mottled and had no pulses.A white fluid discharge was seen around catheter insertion.However, the customer stated that the patient was on a diprivan drip which is white in color.Per the physician order, the catheter was removed.Ultrasound of leg showed occlusion and required intervention.The physician who completed the intervention believes the mottled skin was due to arterial placement.The patient expired due to reasons unrelated to the catheter.Patient had a few comorbidities and that gave her a decreased ability to survive.The customer did not attributed the catheter to the patient death, and agrees that this was a user error.The quattro catheter is indicated only for the femoral placement and it is not to be placed in artery.
Additional Manufacturer Narrative
The suspected leak of the catheter was not confirmed during the functional testing of the device.Even though a bent shaft was observed during the visual testing, there were no leak observed during the functional testing.The balloons deflated successfully with no issue.A visual inspection of the returned catheter was performed.Bent shaft between the medial 2 and proximal of the quattro catheter were noted.The balloons were examined and there were no tears, balloon bond detachment or rupture.During functional testing, the catheter was connected to a pressurized inflation device.Capping the "out" luer and connecting the "in" luer to the pressure inflation device.The catheter was pressurized up to 100 psi and the pressure was observed for one minute without any leak.Following the test, all balloons deflated successfully without any issues.During manufacturing, all quattro catheters are 100% inspected for leaks.Only units that passed are moved to the next process.

• 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: 6637289
• Report Number: 3010617000-2017-00424
• Device Sequence Number: 16165918
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 07/28/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8700-0791-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1