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

Model Number 1261.306

Device Problems Break (1069); Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

The complaint investigation is currently in process, and the results will be communicated to fda within thirty days of its conclusion via follow-up mdr.

Event Description

During dressing change, the catheter was torn off and separated unnoticed.Two hours later the puncture site of the premicath was checked but only the proximal part of the premicath (small piece of the catheter, fixation wing and hub) was found.At first, it was assumed that the rest of the catheter had remained in the patient and had been washed into the vein, as the ""breakage"" suggested this.And after a visual check of the veins, a change in the arm vein had probably been detected by the doctor and the surgeon.The surgeon then wanted to remove the remaining catheter from the child (surgical intervention).Then, during the procedure, it became clear that there was no catheter tube to be found in the patient's veins.This was also confirmed by the x-ray check after (!) the surgical intervention.Then the catheter end was finally found in the removed dressing, which was disposed of in the morning (was wrapped in the rubbish bin in the dressing).Consequently, the catheter end was torn off during the dressing change.".

Manufacturer Narrative

We received a premicath as a sample, which was torn into two parts immediately distal to the 28 cm mark.The proximal part was still stuck in a 24 g cannula and the catheter tube was torn approx.2 mm distal to it.The catheter tube was obviously elongated to the last cm (starting at about 24 cm) before it ruptured.Microscopic examination of the fracture surfaces showed the typical rough and uneven surface for a tensile fracture.The delicate catheter should not be subjected to a higher tensile load.According to the customer's statement, this probably happened unnoticed during the dressing change, which is why it was initially discarded with the torn catheter.There was a surgical procedure to retrieve the catheter that was supposedly washed in.Only when it became clear that the catheter had not been washed in, was this also confirmed by an x-ray check.The torn catheter was later found in the removed and disposed dressing.There were no abnormalities when checking the batch documentation.A leakage and flow test is carried out on each catheter.A tensile strength test is carried out randomly as an in-process test.The tensile force of the involved catheter batch was 4.5 n and thus met our specification (min.1.5 n).Finally, there are two 100% completeness visual inspections and a sealed seam inspection as well as an incoming goods inspection for all components are carried out.There are 8 further complaints for ch.-no.060720gn and 5 further complaints concerning a torn catheter tube during the lying time for ch.-no.1261.306 within the last three years.No further measures are taken by quality management, as there are no indication of a product-related defect.

Event Description

During dressing change, the catheter was torn off and separated unnoticed.Two hours later the puncture site of the premicath was checked but only the proximal part of the premicath (small piece of the catheter, fixation wing and hub) was found.At first, it was assumed that the rest of the catheter had remained in the patient and had been washed into the vein, as the ""breakage"" suggested this.And after a visual (!) check of the veins, a change in the arm vein had probably been detected by the doctor and the surgeon.The surgeon then wanted to remove the remaining catheter from the child (surgical intervention).Then, during the procedure, it became clear that there was no catheter tube to be found in the patient's veins.This was also confirmed by the xray check after (!) the surgical intervention.Then the catheter end was finally found in the removed dressing, which was disposed of in the morning (was wrapped in the rubbish bin in the dressing).Consequently, the catheter end was torn off during the dressing change.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen PA 52070 ; GM 52070
• Manufacturer (Section G): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 12487687
• MDR Text Key: 271897051
• Report Number: 2245270-2021-00108
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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 Model Number: 1261.306
• Device Lot Number: 060720GN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention