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

Catalog Number	8700-0781-01
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
As reported, prior to insertion the attending physician observed the balloons on the solex catheter had separated from the catheter.According to the reporter, the balloons were not inflated prior to the placement.Another solex catheter kit was obtained.There was no significant delay in the replacement nor was there any report of patient consequence as a result of the issue.
Additional Manufacturer Narrative
Evaluation of the returned catheter could not replicate the customer reported issue.The solex 7 catheter (lot# 71881) functioned as intended.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noted during flushing.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 pressure was increased up to 100psi and no leak was observed.The balloons were able to deflate without difficulties.No leak path was observed when the catheter was pressurized.During manufacturing all solex 7 catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints for solex catheter lot # 71881.

• 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: 6994039
• Report Number: 3010617000-2017-00843
• Device Sequence Number: 19219720
• Product Code: NCX
• UDI-Device Identifier: 00849111075510
• UDI-Public: 00849111075510
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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 Catalogue Number: 8700-0781-01
• Device Lot Number: 71881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 104