MAUDE Adverse Event Report: ST PAUL DELTEC; PORT A CATH

Model Number	21-4591-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical implantable ports|deltec p.A.S.Port ports caused and adverse event.Reported the patient was normal until one month of implantation, the blood could not be drawn out when medicine was injected at the hospital.Film was taken, and it was found that the catheter fell into the heart.Emergency removal was required.Photos of product and xrays attached.This required emergent surgical intervention to remove the disconnect part that fell in to the heart.
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: DELTEC
• Common Device Name: PORT A CATH
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 12325486
• Report Number: 3012307300-2021-08471
• Device Sequence Number: 2754177
• Product Code: LJT
• UDI-Device Identifier: 10610586021565
• UDI-Public: 10610586021565
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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 Expiration Date: 03/23/2024
• Device Model Number: 21-4591-24
• Device Catalogue Number: 21-4591-24
• Device Lot Number: 3892377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1