MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC TITANIUM PORT-A-CATH, LOW PROFILE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4083-24
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One device sample was received in used condition, in a plastic bag.During visual inspection of the device, it was detected that the catheter was broken since a catheter fraction remained on the port-catheter connection section, is also observed that the sleeve is locked/activated, this prevents catheter to detach from the port, if the catheter is being twisted or stretch while sleeve is locked, this could damage the catheter.The complaint was confirmed due to a breakage on the catheter.The root cause cannot be associated with the manufacturing process since the failure could not be reproduced following assembly process, and per verification performed by production and quality personnel.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective actions were taken since the root cause could not be attributed to the manufacturing process.
Event or Problem Description
It was reported that an interventionalist performs an infusion port implantation procedure on the patient, and the patient underwent chemotherapy and radiotherapy for nearly a year after surgery.Recently, a poor infusion was noted, and imaging revealed a broken catheter and that the broken end had slipped through the superior vena cava into the heart.Subsequent intervention was performed to remove the catheter and remove the port.There was patient involvement and no patient harm/adverse event reported.

• Brand Name: DELTEC TITANIUM PORT-A-CATH, LOW PROFILE
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19469292
• Report Number: 9617604-2024-00507
• Device Sequence Number: 19681704
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: (01)10610586023613(17)270227(10)4256942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 4256942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY.; RADIOTHERAPY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female