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

Model Number 1261.203A

Device Problems Material Fragmentation (1261); Material Separation (1562); Unintended Movement (3026)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Picc rn placing preemie picc line in 1400 gm infant.Reported easy, uncomplicated insertion process.Rn awaiting x-ray, noted line moved out 1 cm.While reinserting with tweezers, baby twitched leg.Rn felt "slack" and looked down to find end of cath in hand.Picc separated at the 17 cm mark-rest of picc left in leg.Could not manually remove (per x-ray was about 1.5 cm into leg from insertion site).Baby required transfer to (b)(6) and interventional radiology vascular to remove picc.

Manufacturer Narrative

The complaint was forwarded to our parent company in germany for their evaluation.The investigation summary is as follows: we received a catheter as a sample which snapped just proximal the 17 cm marking.Furthermore, we received the two halves of the peelable needle, the stylet with y-piece, curved and grooved forceps, and a filled 5 ml syringe, all placed in the product's blister.We did not receive the snapped distal fragment of the catheter tube.Microscopic examination shows a very peaked parting surface, which suggests sharp mechanical damage e.G., occurred during peeling process of the needle or handling with the toothed forceps.As a result of this damage, the catheter tube snapped off under light tension.There is a statement in the product's ifu: "(puncture with breakaway needle, peelable cannula or neocath split): insert the catheter through the needle/cannula, using non-toothed forceps.Advance the catheter using short, steady strokes.(feeding the catheter with an anatomical forceps)" and "do not use small syringes as these can generate very high pressures." a review of the batch history records was performed, and no deviations were found.Each catheter is flow and leak tested during production.The tensile force and dimensions of catheter components are randomly checked as well as an incoming goods inspection and two 100% visual tests after packaging is carried out, we have 5 further complaints for the involved batches, but this is the very first complaint regarding a catheter tube which snapped off on code 4g07126104 within the last three years.No further corrective action initiated by quality management as there are no indications of a manufacturing fault.Corrective action: no further corrective action will be initiated by quality management at this time as there are no indications of a manufacturing root cause.However, both vygon usa and germany will continue to monitor this issue.

Event Description

Picc rn placing preemie picc line in 1400gm infant.Reported easy, uncomplicated insertion process.Rn awaiting x-ray, noted line moved out 1 cm.While reinserting with tweezers, baby twitched leg.Rn felt "slack" and looked down to find end of cath in hand.Picc separated at the 17cm mark-rest of picc left in leg.Could not manually remove (per x-ray was about 1.5cm into leg from insertion site).Baby required transfer to sacred heart medical center and interventional radiology vascular to remove picc.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• MDR Report Key: 11782844
• MDR Text Key: 249300824
• Report Number: 2245270-2021-00074
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1261.203A
• Device Lot Number: 18H025D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 WK
• Patient Weight: 1