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

Model Number 1261.206

Device Problems Material Fragmentation (1261); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2022

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

During slow withdrawal of the catheter after a period of 5 weeks, initially difficult withdrawal, but catheter can be mobilized, then suddenly rupture at 6 cm.The torn catheter must be interventionally removed at a later time.

Manufacturer Narrative

As a sample we received a catheter that had ruptured at approx.6.5 cm.The catheter was still in a 26 g cannula, which was connected to the pink adapter.We did not receive the distal catheter fragment.The catheter tube was severely elongated from distal to about the 10 cm mark.It was possible to flush the catheter directly.At about 8.5 cm, a small leak was visible.A microscopic examination showed a small longitudinal tear and a slightly inflated catheter tube at this point.Therefore, a burst due to excess pressure is to be suspected here.The fracture site at the distal tip showed a rough surface typical of a tensile fracture.A small mechanical damage was visible about 0.5 mm proximal to the rupture site, furthermore a kind of constriction at about 1.5 cm from distal.It is unclear at what time this damage occurred, but it can be excluded that the catheter was damaged in this way during production.There were no abnormalities on review of the batch documentation[?]no discrepancies or deviations.A leakage and flow test is carried out on each catheter.A random tensile strength test is carried out as an in-process test.Finally, there are two 100% completeness visual inspections and a seal seam inspection.There is an incoming goods inspection for all components.The average tensile value of the catheter tube batch involved was 5.6 n, which exceeds our specification (according to iso 10555 (minimum 1.5 n)).No fibrin deposits were visible on the catheter tube that could have justified difficult removal.The catheter was in use for 5 weeks (35 days) and when trying to remove it, it broke.In the ifu: "the catheter is used for short- and medium-term infusion of tpn or intravenous medications for a period of up to 29 days." therefore the device was not used per ifu.This is the first complaint regarding batch 210621gn and there are three other complaints regarding a torn catheter tube during removal for code 1261.206 within the last three years.This defect is already considered in the risk analysis.The probability of occurrence is acceptable.No further actions are taken by qm, as there is no indication of a production-related or design-driven defect.

Event Description

During slow withdrawal of the catheter after a period of 5 weeks, initially difficult withdrawal, but catheter can be mobilized, then suddenly rupture at 6 cm.The torn catheter must be interventionally removed at a later time.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 13485702
• MDR Text Key: 285357386
• Report Number: 2245270-2022-00008
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/22/2022

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: 1261.206
• Device Lot Number: 210621GN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 03/23/2022
• 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