MAUDE Adverse Event Report: MEDICAL COMPONENTS INC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Lot Number MJLM470

Device Problem Material Fragmentation (1261)

Patient Problems Swelling (2091); Discomfort (2330)

Event Date 12/04/2017

Event Type  malfunction  

Event Description

The team was concerned about patient discomfort when the picc line was manually flushed and called the iv team for a consult as follows: one of the lumens has no blood return.Chest x-ray on this day demonstrated a distinct area of discontinuation of the picc catheter in the region of the left axilla.Based on this finding and patient exam which showed that the area of the right axilla (location of picc line) was more swollen than the left the decision was to remove the line.The iv team determined that bedside removal was too risky.The patient was taken to the or the following day for line removal and remediation.In the or, the surgeon pulled out the picc line under fluoroscopy to the point of the discontinuation which revealed a fracture.There were several cms of intact picc line still in the vein.The fractured portion of the line was cut off and threaded with 0.014 guidewire through the portion of the picc that remained in the vein.The surgeon confirmed that it was in a good position.Using the guidewire with fluoroscopy he then removed the remaining portion of the picc line over the wire.It was clear that the line came out completely intact.It was not clear what had caused the fracture but that the portion that was fractured was 'quite messed up': it almost looked like a 'small grenade had exploded there, so i do not have a good explanation for how it fractured' in that area (wording in ' taken from the surgeons' note).Nonetheless, with the guidewire in place we cut a new picc line to the proper length and passed it over the guidewire.It drew and flushed.Fluoroscopy confirmed good position and this picc was cut to the length of the prior picc line, which was in good position.The picc line was secured and a sterile dressing was applied.The patient tolerated the procedure well.

• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): MEDICAL COMPONENTS INC; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7107837
• MDR Text Key: 94516866
• Report Number: 7107837
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: MJLM470
• Other Device ID Number: CVC- PICC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 9