MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6.6F DIGNITY TITANIUM CT-PORT

Model Number MRDT66AMN

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Operating room staff indicated that the core of the guidewire came out inside the patient during insertion.Physician aborted insertion and asked for another kit.

Manufacturer Narrative

Visual inspection of the returned device confirms the complaint.Approximately 0.02cm of the core wire is sticking out from the coiled section at the "j" portion.The device was forwarded to the contract manufacturer for further evaluation.The contract manufacturer conducted an evaluation of the returned device.A magnification evaluation showed the guidewire welds are intact.However, the fracture occurred on the core straight section ~ 2.5 cm from the distal tip.It was noted that both sides of the core were slightly bent, which could indicate that some force was applied to this point leading to the fracture.No other damage was present on the returned guidewire.When viewed under an electron microscope it was confirmed that the field fracture was not a typical fracture.One of most probable root causes is that an excessive external force was applied to the wire and repeated several times, which could exceed the limits of this high strength material.A review of the manufacture records for the device showed it was manufactured according to specification with no non-conformances or abnormalities.A root cause cannot be determined but is not likely to be manufacture related.

• Brand Name: 6.6F DIGNITY TITANIUM CT-PORT
• Type of Device: DIGNITY TITANIUM CT-PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10792564
• MDR Text Key: 214793093
• Report Number: 2518902-2020-00053
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908147673
• UDI-Public: 884908147673
• Combination Product (y/n): N
• PMA/PMN Number: K980438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MRDT66AMN
• Device Catalogue Number: MRDT66AMN
• Device Lot Number: MNZK260 S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 19