MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number	IPN918779
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during insertion on jugular, the smaller dilatator broke inside the patient and one piece of it remained in.A small cut on the vein had to be done to be able to remove the dilator's piece left inside.Three suture points were needed to close it off.Risk that the dilator's piece would have migrated into the bloodstream.The piece of dilator was removed from the vein entirely.Once out the vein, the dilator broke off into even smaller pieces.As the swg was already in place, the second dilator (longer one) was used instead to successfully finalize the insertion of the cvc".
Event or Problem Description
It was reported that "during insertion on jugular, the smaller dilatator broke inside the patient and one piece of it remained in.A small cut on the vein had to be done to be able to remove the dilator's piece left inside.Three suture points were needed to close it off.Risk that the dilator's piece would have migrated into the bloodstream.The piece of dilator was removed from the vein entirely.Once out the vein, the dilator broke off into even smaller pieces.As the swg was already in place, the second dilator (longer one) was used instead to successfully finalize the insertion of the cvc".
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided two photos for analysis.Visual analysis of the supplied photos revealed that the dilator body separated while inserted into the patient.The dilator was separated into two pieces during use.The customer also returned one dilator (5 fr x 1 5/8") for investigation.Visual analysis revealed that the dilator body was separated into three pieces.One separation was located adjacent to the juncture hub, and the other was at the proximal end of the dilator body.The separation adjacent to the juncture hub was not observed in the customer photos, so it is possible that this separation occurred after the device was removed or during transport of the device for investigation.Microscopic examination confirmed the damage and revealed rough, jagged, non-uniform points of separation.This damage would not be indicative of any contact with sharps during use.The points of separation measured 1/16" and 1/2" from the juncture hub.The length of the dilator measured 1 5/8", which is within the specification limits of 1 3/8"-1 7/8" per the dilator product drawing.This indicates that all pieces of the dilator were removed from the patient and returned for investigation.The dilator outer diameter measured 0.0685", which is within the specification limits of 0.068"-0.070" per the dilator extrusion drawing.The inner diameter at the distal tip measured 0.040", which is within the specification limits of 0.038"-0.041" per the dilator extrusion drawing.Functional testing could not be performed due to the condition of the returned sample.However, manual force was applied across the undamaged dilator body portions to gauge the condition of the extrusion.Upon application of light manual force, the dilator extrusion was easily broken and separated.The fracture was consistent with the damage observed on the returned sample.The extrusion was determined to be brittle in nature which allowed for it to easily fracture.R & d engineering and manufacturing were contacted as part of this complaint investigation.R & d confirmed that the resin used to construct the dilator extrusion is a highly dense polymer material that should withstand bending under normal conditions.Although the root cause of this event has not been determined, a nonconformance has been initiated to the manufacturing facility to further evaluate this issue.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a separated dilator was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the dilator body was separated into three pieces.One separation was located adjacent to the juncture hub, and the other was at the proximal end of the dilator body.The points of separation were rough, jagged, and non-uniform which would not be indicative of any contact with sharps during use.Although functional testing could not be performed, manual force was applied across the undamaged dilator body portions to gauge the condition of the extrusion.Upon application of light manual force, the extrusion was easily broken and separated.The extrusion was determined to be brittle in nature which allowed for it to easily fracture.R & d engineering and manufacturing were consulted and confirmed that the resin used to construct the dilator extrusion is a highly dense polymer material that should withstand bending under normal conditions.Although the root cause of this event has not been determined, a non-conformance has been initiated to the manufacturing facility to further evaluate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21313940
• Report Number: 3006425876-2025-00124
• Device Sequence Number: 8083875
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)230221(17)280131(10)71F23B1234(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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 Model Number: IPN918779
• Device Catalogue Number: CS-14402
• Device Lot Number: 71F23B1234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 4 MO
• Patient Sex: Male
• Patient Weight: 7 KG