MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5FX55CM DUAL PRO PICC CT-BASIC; PRO-PICC CT

Model Number	MR17035201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional 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 available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Attempted at puncture of picc performed according to medical request.Venous network evaluated with usg aid and left basic vein selected for puncture.Started the guided procedure with usg.Needle puncture performed and after venous return inserted approximately 4 cm from the guide wire and there was resistance, opted for the removal of the guide wire to reposition the needle, but when attempting to remove the guide wire, it did not come out, needle pulled out and removed but the guide wire is not, yet it went out.Medical communication who evaluated and was not able to remove the guide wire even after performing a pic on the skin.I also inform that the site has no active bleeding, showing that the guide wire possible was in the subcutaneous tissue.After performing x-ray, it showed a fold in the tip of the guide wire.Vascular physician performs removal by traction and after a new x-ray, the presence of a remaining fragment in the subcutaneous tissue was evidenced.Patient will be submitted to dissection for fragment removal.
Additional Manufacturer Narrative
The pro picc was returned for evaluation with the sideport attached and the twisted wire stylet inserted into the sideport.The guidewire and needle reported in this complaint were not returned.The guidewire 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.Without an evaluation of the complained device a root cause cannot be determined.The instructions for use (ifu) contains the following warnings and precautions: *do not advance the guidewire or catheter if unusual resistance is encountered.*do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the introducer needle or sheath/dilator and guidewire must be removed together.*guidewire is hydrophilic.Hydrate prior to use.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: 5FX55CM DUAL PRO PICC CT-BASIC
• Common Device Name: PRO-PICC CT
• 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: 15348186
• Report Number: 2518902-2022-00052
• Device Sequence Number: 14738483
• Product Code: LJS
• UDI-Device Identifier: 00884908033250
• UDI-Public: 884908033250
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: 10/01/2024
• Device Model Number: MR17035201
• Device Catalogue Number: MR17035201
• Device Lot Number: MPWZ930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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 Sex: Unknown