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

Model Number 1261.306

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation and investigation.The results of this investigation will be sent to fda in a follow-up mdr with in thirty days of its conclusion.

Event Description

When withdrawing the catheter after 10 days it snapped and approximately 6 cm were still inside the patient and surgically have to be removed.

Manufacturer Narrative

The complaint is not confirmed.We received the involved sample in 2 parts: first, the catheter fragment, which had ruptured proximal the 6 cm marking and had to be surgically removed, and the proximal catheter part, with an extension line and connected to a 5 ml syringe.The catheter tube had been extremely elongated.A microscopic examination showed the typical breaking edges for excessive tensile stress and the resulting tear.The distal catheter section of the fragment showed severe fibrin formation and the distal tip was half-closed (blood coagulation, fibrin).The catheter had been in place for 10 days.Probably a layer of fibrin had formed on the catheter and then allowed it to adhere to the vein wall.It is known from the technical literature that a calcified fibrin coating can form on the catheter after just 24 hours of exposure, which, if it grows together with the vein wall, can prevent or even make it impossible to remove the catheter.In addition, when removing with forceps, care must be taken to ensure that the forceps are atraumatic.In the instructions for use we have two corresponding notes - the last one could rather lead to a fibrin formation and thus to an adhesion in the vessel."caution: do not over stretch the catheter as it may rupture, causing a catheter embolism." "before handling the product, we recommend that powdered gloves should be washed to remove all residue of starch or glove powder" in case of recurrence we recommend trying the "splint traction method".There were no abnormalities when checking the batch documentations.A leak and flow test is performed on each catheter prior to packaging.A tensile strength test is carried out on a random basis as an in-process test.In addition,100% visual inspections are performed twice and a seal seam inspection.An incoming goods inspection is carried out for all components.This is the second complaint regarding the possibly involved batches 160119gn, 140619gn and 131219gn.And this is the 19th complaint regarding a snapped 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 for a manufacturing fault.

Event Description

When withdrawing the catheter after 10 days it snapped and approximately 6 cm were still inside the patient and surgically have to be removed.

• 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: 10239013
• MDR Text Key: 197747827
• Report Number: 2245270-2020-00053
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: 131219GN,140619GN OR 160119GN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention