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

Model Number 8700-0671

Device Problems Material Separation (1562); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The zoll catheter in complaint was returned to zoll on 04/15/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that the physician had difficulties inserting the zoll solex 3 lumen catheter, in the patient's vena jugular vein.The physician switch to the zoll cool line catheter.No issues reported.When the solex catheter was examined by the physician, it was noted that the spiral balloon portion was detached from the catheter.There was no patient sequelae reported.No additional information provided.

Manufacturer Narrative

Two solex catheters (s/n (b)(4)) were returned to zoll (b)(4) on 04/15/2016 for evaluation.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing the catheter.The spiral portion was not damaged or detached.Following the test, all balloons deflated successfully without any issues.Device history record was reviewed for balloon bonding lot no 56974 found no nonconformities with the lot.Evaluation of the returned device did not confirm the customer reported issue.The probable cause for the customer reported experience was due to operational context, including, but not limited to patient's skin condition.There was no patient injury or death attributable to this complaint.

• Brand Name: ZOLL IVTM SOLEX CATHETER
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5598772
• MDR Text Key: 43350481
• Report Number: 3010617000-2016-00280
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K081936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0671
• Device Catalogue Number: 8700-0671-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1