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

Model Number 1261.203

Device Problems Material Fragmentation (1261); Material Separation (1562); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon for device evaluation as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion.

Event Description

Catheter snapped at the level of the fixation wing when it was removed after 11 days.Catheter fragment of 1,5 cm remains in the patient.Patient transferred to another hospital since the fragment could not be removed.The catheter migrated to superior vena cava and requires surgical intervention to remove it.".

Manufacturer Narrative

The returned sample had been shortened distal at 3,5 cm and snapped just at the junction of catheter tube and extension line.Microscopic examination of the breakage area showed the typical rough surface for a tensile breakage.From previous complaints we know different causes of a tensile fracture: dressing change - in some instances the catheter can become adhered to the dressing and additional pulling is required to free it, placing stress on the line resulting in a tensile fracture; routine care - when lifting the baby to change bedding; movement - the baby themselves catching the line, normally with a foot, during movement.It is essential to let disinfectants dry completely before the catheter is placed, as alcohol or organic solvents can damage the catheter material.Having checked the batch history records, no abnormalities were found.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out.The tensile force for the involved catheter tube/extension line was between 1,93 n and 3,30 n and therefore within our specification (1,5 n).This is the 6th complaint for batch 140818gm and the 37th regarding a snapped catheter on code 1261.203 within the last three years.For your information, the general complaint rate for code 1261.203 from 2015 to 2018 is at 1,12 [?].As the catheter worked well for 11 days a manufacturing fault can be excluded and no further corrective action initiated by quality management." this complaint is not confirmed.

Event Description

Catheter snapped at the level of the fixation wing when it was removed after 11 days.Catheter fragment of 1,5 cm remains in the patient.Patient transferred to another hospital since the fragment could not be removed.The catheter migrated to superior venacava and requires surgical intervention to remove it.".

• 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: 8680192
• MDR Text Key: 147444278
• Report Number: 2245270-2019-00033
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1261.203
• Device Lot Number: 140818GM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention