MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. PRO-PICC® CT; PRO-PICC CT

Model Number	MRCTP41028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The guidewire was returned for evaluation in three (3) pieces.The longer piece was coiled around itself and secured with excessive tape.A smaller, unraveled piece was also taped to the longer piece.A third piece was returned with the outer coil unraveled on one end and a knot in the opposite end.Visual inspection revealed a great deal of tissue entangled in the knot.Relative measurements were taken on the non-damaged portions of the wire and found the device to be within specification.The returned device was evaluated by medcomp engineering.Multiple tests were conducted attempting to replicate the complaint condition but were not successful.A possible cause of the knotted tip could be a back-and-forth motion during the insertion procedure.This can cause the wire to fold back on itself resulting in a knotted tip.This may also cause the wire to be difficult to remove, resulting in applying more forces than the device is designed to withstand to remove it.A root cause cannot be determined but is not likely manufacturing related.The instructions for use (ifu) contains the following warnings: 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.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
Basilic vein punctured using introducer needle under u/s guidance-good blood flow through needle.Attempted to pass guidewire via needle, but experienced resistance.Unable to withdraw guidewire.Fluoroscopy of patient's arm-tip of guidewire appeared knotted.Attempts to manipulate wire under fluoroscopic guidance unsuccessful.Attempts to untangle know using 4f dilator unsuccessful.The patient had to go to theatre.

• Brand Name: PRO-PICC® CT
• 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: 20923799
• Report Number: 2518902-2024-00086
• Device Sequence Number: 8314445
• Product Code: LJS
• UDI-Device Identifier: 00884908118032
• UDI-Public: 00884908118032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: Health Professional
• Device Model Number: MRCTP41028
• Device Catalogue Number: MRCTP41028
• Device Lot Number: MRJZ420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2024
• 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 Sex: Unknown