MAUDE Adverse Event Report: VYGON USA PREMICATH; INTRAVASCULAR CATHETER

Model Number	1261.203A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The stylet got stuck in the catheter when trying to remove the stylet.The stylet broke off and the entire picc had to be removed.
Additional Manufacturer Narrative
Device will be analyzed upon reciept of sample.
Additional Manufacturer Narrative
Correction in yes a sample is available, added expiration date and udi number, selected yes the product was labeled for single use, and added manufacturer name.
Event or Problem Description
The stylet got stuck in the catheter when trying to remove the stylet.The stylet broke off and the entire picc had to be removed.
Event or Problem Description
The stylet got stuck in the catheter when trying to remove the stylet.The stylet broke off and the entire picc had to be removed.
Additional Manufacturer Narrative
This complaint is not confirmed.According to the complaint form, we got the following information: "the stylet got stuck in the catheter when trying to remove the stylet.The stylet broke off and the entire picc had to be removed.".We received a catheter and the y-piece.The stylet is missing.Due to the flexibility of the catheter tube and the fact that in transmitted light no stylet was visible along the catheter tube, no stylet is included.No stylet is remaining inside the catheter tube.Therefore, we can not comprehend the complaint's reason.Microscopic examination of the y-piece demonstrated a clear imprint inside the gluing of the cap confirming that the stylet had been correctly clamped.The stylet obviously came out of the y-piece.This is a safety feature to prevent further stylet rupture inside the catheter tubing.At this point at the latest, no further force should be applied for the removal of the stylet, otherwise, the stylet may break.It is not possible to check whether this has happened in this case, as the stylet is missing.We have made several images.We have special hints in the product's ifu regarding problems during stylet removal: "if difficulty is experienced removing the stylet stop, let vein rest for a minute and try removal again very slowly.Gentle flushing of the catheter with saline may assist in guidewire removal.".Having checked the batch history records, no deviations were found.The batch complied with its specifications and was released.Each catheter is flow and leak-tested during production.The tensile force of the catheter components is randomly checked.According to our specification, the min value of 3.1 n is requested regarding the tensile force stylet out of y-piece.For the involved code 4g31261420, for batch 8164992 the range was between 3.80 n and 7.55 n, for batch 8167487 the range was between 4.19 n and 6.94 n.According to our specification, the min value of 9.0 n is requested regarding the tensile force of the stylet.For the involved code 7g12565010, for batch 0343963001 the range was between 9.39 n and 10.9 n.All values are within the specification respectively higher than the requested 3.1 or 9.0 n.Visual tests and incoming goods inspections are carried out.There is one further complaint for batch 8172418 and five further complaints regarding a stylet detached from the y-piece on code 4g07126104 within the last three years.This query relates to all complaints that have come to our attention worldwide.Corrective action: no further corrective action was initiated by quality management as there are no hints of a manufacturing fault.
Event or Problem Description
The stylet got stuck in the catheter when trying to remove the stylet.The stylet broke off and the entire picc had to be removed.
Additional Manufacturer Narrative
The manufacturer needs more time to evaluate the sample.

• Brand Name: PREMICATH
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: wanda dumont ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 17713062
• Report Number: 2245270-2023-00060
• Device Sequence Number: 6749415
• Product Code: LJS
• UDI-Device Identifier: 00849884002270
• UDI-Public: 00849884002270
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 1261.203A
• Device Lot Number: 22K020D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 09/06/2023; 09/06/2023; 09/06/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/13/2023; 10/12/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 WK
• Patient Sex: Male
• Patient Weight: 1 KG