MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 7 HEPARIN CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-4593
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed when the product is returned and investigation has been completed.
Event or Problem Description
As reported, during solex 7 catheter (lot number unknown) insertion on a patient, customer observed catheter's tip tore off.A new catheter was placed on the patient and therapy continued.No known impact or consequence to patient was reported.
Additional Manufacturer Narrative
The reported complaint of a tore off tip of the solex 7 catheter was not confirmed during visual inspection and functional testing.A visual inspection of the returned catheter was performed and found no physical damage.The serpentine balloons were examined and there were no tears, balloon bond detachment or rupture.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device, the balloons fully inflated when pressurized up to 100 psi without any issues.The balloons did not leak during inflation and deflation.No leak was observed.All lumens flushed as intended.During manufacturing, all catheters are 100 % inspected.Only units that pass are moved to the next process.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for solex 7 catheter with lot number 78162.

• Brand Name: ZOLL IVTM SOLEX 7 HEPARIN CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7830537
• Report Number: 3010617000-2018-00873
• Device Sequence Number: 1287523
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: IC-4593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 78162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1