MAUDE Adverse Event Report: VYGON GMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1261.306

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

Sample will be returned to vygon and will be evaluated as part of the complaint investigation.The results of this investigation are still pending and will be communicated with fda within 30 days of completion.

Event Description

The 30cm premicath was placed over the left foot on (b)(6) 2020.A position control with sonography and x-ray thorax was performed.The premicath was located in the inferior vena cava.Infusion and medication could be administered without any problems.On (b)(6) 2020 an attempt was made to pull the premicath back, about 3cm could be pulled back without any problems, then a resilient resistance.An attempt was made to mobilize the premicath by turning it slowly with tweezers.The premicath immediately snapped.Thereupon surgical removal of the premicath was necessary.After removal, the premicath was inspected and broke again without any force.10 days lying in bed, therapy glucose 10%, nacl 5.85%, potassium chloride 7.45% (kcl) --> 2ml/h flow rate.

Event Description

The 30cm premicath was placed over the left foot on (b)(6) 2020.A position control with sonography and x-ray thorax was performed.The premicath was located in the inferior vena cava.Infusion and medication could be administered without any problems.On (b)(6) 2020 an attempt was made to pull the premicath back, about 3cm could be pulled back without any problems, then a resilient resistance.An attempt was made to mobilize the premicath by turning it slowly with tweezers.The premicath immediately snapped.Thereupon surgical removal of the premicath was necessary.After removal, the premicath was inspected and broke again without any force.10 days lying in bed, therapy glucose 10%, nacl 5.85%, potassium chloride 7.45% (kcl) 2ml/h flow rate.

Manufacturer Narrative

We received three catheter fragments as reference samples for this complaint.The first fragment was the catheter tip up to approx.11.3 cm.The second fragment had a length of approx.14 cm and extended to the end of the 25 cm mark.The third fragment was the proximal rest of the catheter tube (with a 30 cm mark) and was still in a cut cannula.Microscopic examination showed some lighter fibrin on the tube fragments, especially on fragment 1 and 2.All fractures of the catheter tubing showed a rough surface, the typical appearance of a fracture under too high tensile force.In addition, the proximal end of the second fragment showed some radial cracks, as they can occur when the catheter tube is stretched.Fibrin formation indicates a patient reaction.This can occur in very rare cases and have various reasons: allergic reaction of the patient to latex, if latex gloves (also unpowdered) are worn when inserting the catheter.Allergic patient reaction to pur (in very rare cases).Poor/unfavorable catheter placement, so that the intima is irritated by catheter movements.Presence of hospital bacteria (at the catheter tip).There were no abnormalities when checking the batch documentation.A leak and flow test are performed on each catheter.A tensile strength test is carried out on a random basis as an in-process test.The tensile values of the pure catheter tube were 3.7 n and therefore conformed to our specification (min.1.5 n).Finally, there are two 100% completeness visual inspections and a sealed seam inspection.For all components there is an incoming goods inspection.This is the fourth complaint regarding batch 280120gn and the 22nd complaint regarding a broken catheter tube for code 1261.306 within the last three years.The general complaint rate for code 1261.306 in the years 2015 to 2018 is 3,75 % no further corrective action initiated by quality management as there are no indications of a manufacturing fault.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• MDR Report Key: 10655883
• MDR Text Key: 210617783
• Report Number: 2245270-2020-00097
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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
• Device Operator: No Information
• Device Model Number: 1261.306
• Device Lot Number: 280120GN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention