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
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of dilator body separated during use cannot be confirmed by the photo as it revealed an intact dilator body.The dilator body appeared to be slightly bent in the photo; however, this was not reported by the customer and the exact details pertaining to how and when the dilator may have been bent are unknown.A complete visual inspection could not be performed as no sample was returned for analysis.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 complaint of dilator body separated during use cannot be confirmed by the photo as it revealed an intact dilator body.The dilator body appeared to be slightly bent in the photo; however, this was not reported by the customer and the exact details pertaining to how and when the dilator may have been bent are unknown.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.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: 21313857
• Report Number: 3006425876-2025-00125
• Device Sequence Number: 8083867
• 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?: No
• 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: 03/05/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 23 KG