MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-15703
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the cvc placement procedure, the attending physician, attempting to remove the guidewire to introduce the cvc, experienced difficulty removing it because it stretched like chewing gum and became soft and tortuous.Two more attempts were made, but the same failure was detected.A total of three cvc devices were found to have failures." there was no medical intervention required.The patient's current was transferred to a different hospital.Associated mdr numbers include: 9680794-2025-00951, 9680794-2025-00950.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided one photo and two videos for analysis.The complaint of an unraveled guide wire was able to be confirmed by the photo and videos.The videos/image show a used guidewire with evidence of unraveling, however, a complete visual inspection to determine the cause of the damage 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 ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The customer report of an unraveled guide wire was confirmed by visual inspection of the customer supplied photo and videos.The videos/image show a used guidewire with evidence of unraveling.A device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event; however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the device being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the cvc placement procedure, the attending physician, attempting to remove the guidewire to introduce the cvc, experienced difficulty removing it because it stretched like chewing gum and became soft and tortuous.Two more attempts were made, but the same failure was detected.A total of three cvc devices were found to have failures." there was no medical intervention required.The patietn's current was transferred to a different hospital.Associated mdr numbers include: 9680794-2025-00951, 9680794-2025-00950, and 9680794-2025-00942.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23585425
• Report Number: 9680794-2025-00942
• Device Sequence Number: 9578035
• Product Code: DQY
• UDI-Device Identifier: 10801902105339
• UDI-Public: (01)10801902105339(11)240709(17)280831(10)14F24G0075(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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
• Device Catalogue Number: CV-15703
• Device Lot Number: 14F24G0075
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2024
• 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: 51 YR
• Patient Sex: Unknown