MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. VASCU-PICC®

Model Number	MRVSP26001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Red lumen of the picc was clotted, alteplase was instilled for about 2 hours.Nnp flushed the lumen and another round of alteplase was to be ordered.Before then rnc to bedside to visualize the picc line site.There was fluid under the dressing at the insertion site.Rnc flushed red lumen and visualized the flush coming out from the insertion site.When flushed again the red lumen leaked out from the insertion site and the site puffed up slightly.Line ordered to be discontinued.
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation with approximately 16 cm of lumen attached.Visual inspection revealed a lengthwise split in the lumen approximately 1 cm from the hub and continuing down another 1 cm.Under magnification it can be seen that the edges of the split have curled over, indicative of the lumen stretching prior to bursting.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacturing process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.The device was implanted for over one month and functioned as designed with no prior issues.A root cause cannot be determined but is not likely manufacture related.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) include warnings and parameters for infusion equipment and bolus injections to avoid excessive pressures.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Do not flush against resistance.

• Brand Name: VASCU-PICC®
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 20373817
• Report Number: 2518902-2024-00066
• Device Sequence Number: 11684810
• Product Code: LJS
• UDI-Device Identifier: 00884908163391
• UDI-Public: 00884908163391
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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?: No
• Operator of Device: Other
• Device Expiration Date: 04/30/2025
• Device Model Number: MRVSP26001
• Device Catalogue Number: MRVSP26001
• Device Lot Number: MMKX390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 MO
• Patient Sex: Male
• Patient Weight: 4 KG