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

Model Number 1261.206

Device Problems Break (1069); Material Fragmentation (1261); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.

Event Description

After two days the catheter tube ruptured at approx.20 cm; migration of catheter fragment into central venous vessels (thorax); catheterization was required.On (b)(6) 2021 the premicath catheter was placed.During the catheter change ((b)(6) 2021), a bouncy resistance was noticed when pulling out the catheter after 3 cm out of 15 cm, an ultrasound examination does not reveal any evidence for the problem of pulling out.On further attempt, the catheter snapped off and the remaining 12 cm stayed stuck in the blood vessel.On (b)(6) 2021, the remaining catheter is removed in the course of an abdominal operation theatre.The removal of the rest proves to be simple and problem-free.All catheter parts with accessories were retrieved.

Manufacturer Narrative

For this complaint, we received the two catheter fragments - the distal approx.11.9 cm piece of tubing, which was surgically removed, and the proximal part of the catheter (catheter tubing in yellow 24g cannula, pink adapter and extension line).Microscopic examination revealed a rough surface at the site of rupture of both catheter fragments, which is typical of a tension rupture.Radial mechanical damage was visible on the proximal catheter tube approximately 0.3 mm proximal to the fracture site.It is unclear at what point this occurred.It can be excluded that the catheter was damaged in this way during production.No fibrin deposits were visible on either of the two pieces of tubing, which could have justified difficult removal.An elongated dried residue (blood, medication?) protruded from the catheter tip.This could be pushed out further and covered a length of approx.3 mm.Other occlusions were visible in the distal catheter piece.There were no abnormalities on checking the batch documentation.A leakage and flow test is performed on each catheter.A tensile strength test is carried out at random as an in-process test.The tensile force of the catheter tube batch involved was 5.3 n and thus within the specification (at least 1.5 n).This is the first complaint regarding batch 101220gn and there have been two further complaints regarding code 1261.206 within the last three years, in which the catheter tube snapped during removal process.No further action is performed by quality management, as there is no hint for a product-related defect.

Event Description

After two days the catheter tube ruptured at approx.20 cm; migration of catheter fragment into central venous vessels (thorax); catheterization was required.On (b)(6) 2021 the premicath catheter was placed.During the catheter change ((b)(6) 2021), a bouncy resistance was noticed when pulling out the catheter after 3 cm out of 15 cm, an ultrasound examination does not reveal any evidence for the problem of pulling out.On further attempt, the catheter snapped off and the remaining 12 cm stayed stuck in the blood vessel.On (b)(6) 2021, the remaining catheter is removed in the course of an abdominal operation theatre.The removal of the rest proves to be simple and problem-free.All catheter parts with accessories were retrieved.

• 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: 12360089
• MDR Text Key: 267883142
• Report Number: 2245270-2021-00102
• 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: 09/27/2021

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 Operator: No Information
• Device Model Number: 1261.206
• Device Lot Number: 101220GN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention