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

Catalog Number 21-4055-24

Device Problem Material Rupture (1546)

Patient Problem Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that 10-20 days following implant of a smiths medical port-a-cath®ii implantable access systems the skin is reported to rupture causing the chamber to come out.Subsequently, the patient was brought to surgery for intervention which was reported to delay chemotherapy treatment.No further adverse effects were reported.

• Brand Name: PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7350679
• MDR Text Key: 102803835
• Report Number: 3012307300-2018-00635
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586023552
• UDI-Public: 10610586023552
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K962695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/19/2021
• Device Catalogue Number: 21-4055-24
• Device Lot Number: 3349908
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention