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

Model Number 2184.00

Device Problems Material Fragmentation (1261); Material Rupture (1546); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to vygon for evaluation, but the details of the complaint will be examined during 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

After two days the catheter tube ruptured at approx.20 cm; migration of catheter fragment into central venous vessels (thorax); catheterization was required.

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.

Manufacturer Narrative

We received a catheter as a sample, on which the catheter tube snapped just distal the first (distal) ring of the 20 cm-marking.The tensile breakage area is smooth but shows a little peak which could be the result of a pressure burst.A high-viscosity drug was still in the catheter, but could be flushed out after a few attempts.We did not get informed about the size of the syringe used, just the information."has required increased cannula parameters under flow".This statement supports the assumption of a poorly passed, blocked catheter, which ultimately leads to too high pressure.The distal fragment of the catheter that needed to be removed surgically, was not returned for analysis.Concerning pressure bursts we have a statement in the product's ifu: "caution: do not use small syringes (<10ml) as these can generate very high pressures.It is possible to generate 4 or 5 times the maximum safety pressure, with any size of hand held syringe.Subjecting the catheter to pressure above 1.2 bar can result in catheter rupture and embolism." and "important cautions in use: 1.Do not use infusion equipment which can exceed the working pressure of 1,0bar max/760 mm hg.2.Bolus injections should be slow and must not exceed the maximum bolus pressure of 1,2bar/900 mm hg.3.Do not use syringes smaller than 10 cc.Smaller syringes generate higher pressures than larger ones." having checked the batch history records, no deviations were found.The batch complied to its specification and was released.Each catheter is flow and leak tested during production.The tensile force and dimensions of catheter components are randomly checked.Incoming goods inspections and two 100% visual tests after packaging are carried out.The tensile force for the involved catheter tube 6g33820000, batch 8075646 was between 2.19 n and 3.16 n and therefore was within our specification (min.1.5 n).This is the first complaint for batch 060520gg and the 21st complaint regarding a snapped catheter tube on code 2184.00 in the last three years.For your information, the general complaint rate for code 2184.00 from 2018 to 2020 was at (b)(4).No further corrective action was initiated by quality management asthere are no indications of a manufacturing defect was found.Thus, as vygon, we do not take the responsibility for this complaint.".

• Brand Name: EPICUTANEO-CAVA CATHETER
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• Manufacturer (Section G): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 12283027
• MDR Text Key: 265240940
• Report Number: 2245270-2021-00098
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K897168
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2184.00
• Device Lot Number: 060520GG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2021
• 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