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, 3012307300-2018-00282.
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 loose length of catheter measuring nine inches was received for investigation.Visual observation of the catheter did not find any holes, however, it did find several longitudinal slits, all approximately ¼ inch in length and located two inches from where it had been attached to the portal.The location and physical characteristics of the slits are consistent with the catheter having been exposed to first rib/clavicle compression syndrome as described in the product instructions for use section ii warnings, 3rd bullet.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.

• 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: 7278792
• Report Number: 3012307300-2018-00283
• Device Sequence Number: 2313890
• 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