MAUDE Adverse Event Report: MEDCOMP UNKNOWN

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

Medcomp received the adverse incident report directly from the (b)(6) in the (b)(6) and immediately contacted our distributor in the (b)(6) and asked them to contact the facility to obtain additional information and the sample if available.At this time the device is unknown.The lot number provided on the report, mlb8580, is not accurate for a medcomp product.

Event Description

A femoral catheter was inserted for hemodialysis access.During the insertion procedure, the catheter and dilators were flushed for patency.With the aid of uss guidance, the vein was punctured in a single attempt with good flows on aspiration.The procedure went through smoothly with cannulation of the vein, and guidewire was inserted under uss guidance.Some resistance was encountered which required repositioning of the needle for smooth insertion of the guidewire.Position of the guidewire into the vein was confirmed on ultrasound.Dilator was passed over the guidewire with full visibility of the wire.The catheter was placed over the guidewire with the wire protruding/visible from the blue lumen.The catheter was inserted successfully and the guidewire was extracted with mild resistance.Confirming good aspiration from both lumens the catheter was sutured in place and patient was moved for dialysis.Reviewing the patient and catheter on dialysis, it was noted that a metallic object was protruding from the blue end of the catheter.The sutures were cut and the catheter position was manipulated, which helped to push the guidewire further towards the surface where it was then pulled out.A section of the guidewire was extracted from the femoral catheter.The end of the wire was curved which confirmed this was the end point of the guidewire.The patient remained well during and after the procedure.

Manufacturer Narrative

Insufficient information was provided to complete an investigation.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8592747
• MDR Text Key: 144972511
• Report Number: 2518902-2019-00031
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention