MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4471-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See mfr: 3012307300-2018-00279, 3012307300-2018-00280, 3012307300-2018-00281, 3012307300-2018-00283.
Event or Problem Description
It was reported that the explanting doctor noticed holes in the catheter of a deltec® port-a-cath®ii power p.A.C.Implantable access system.Issues with the catheter had to be explanted when one patient complained of pain.There was no patient injury associated with this occurrence.
Additional Manufacturer Narrative
One used deltec® port-a-cath®ii power p.A.C.Implantable access system with a length of attached catheter and an unattached length was received for investigation.A visual inspection was performed and found that the distal end of the attached catheter and the proximal end of the unattached catheter to have smooth ends and matched up when compared together, consistent with having been cut by a sharp instrument (most likely during explant).The 8.5 inch of catheter was found to have no holes or abnormalities.The attached one inch catheter was found to have a longitudinal spilt where it coincides with the maximum diameter of the outlet tube.The split may be consistent with the catheter having been bent (flexed) for an extended period of time.No root cause could be determined.

• Brand Name: DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• MDR Report Key: 7278791
• Report Number: 3012307300-2018-00282
• Device Sequence Number: 2273805
• Product Code: LJT
• UDI-Device Identifier: 10610586032745
• UDI-Public: 10610586032745
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4471-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention