MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL VASCU-PICC

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Additional information has been requested.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.
Event or Problem Description
Line placed in left femoral vein by ir both lumens ruptured between the 8cm and 9cm mark.The nurses reported that they had been having to tpa the line frequently to obtain labs.A sono was performed to look for any anomalies and what appeared to be a thrombus was observed.Patient was being treated for thrombus and it was determined that due to multiple tpa infusions and complications with the line, that the line needed to be removed.I then removed the line without difficulty, and observed a "flattened" area between the 8cm mark and the 9cm mark.I brought the line to the ir physician, and upon further investigation, it was determined that both lumens appeared ruptured.The ir physician reviewed the sono and radiographic films, and it was thought that the "rupture" area was at a flexion point and that may have been the contributing factor for the ruptures.The line was then discarded.
Additional Manufacturer Narrative
No device was returned and no photographs provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation showed the device was manufactured according to specification with no non-conformances or abnormalities.Without an evaluation of the device a root cause cannot be determined.The report indicated they needed to use tpa (thrombolytic agent) in order to be able to withdraw blood for labs.This would indicate that the line was clotted.The instructions for use (ifu) contain the following warning.Do not flush against resistance.Repeated flushing against resistance may have contributed to the lumen rupture.The ir physician also noted the area of rupture was at a flexion point in the lumen which may have a contributing factor.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.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11272127
• Report Number: 2518902-2021-00004
• Device Sequence Number: 584475
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 884908146493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: Other
• Device Expiration Date: 08/01/2022
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MPGT180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 MO
• Patient Weight: 10