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

Model Number	8700-0671
Medical Device Problem Codes	Material Separation (1562); Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5598772
• Report Number: 3010617000-2016-00280
• Device Sequence Number: 18931031
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K081936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2016

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: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2016
• Supplement Report FDA Received Date: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1