MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35041-HPHNM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "catheter kinking and breakage issue reported from cvad department.The department have shared images of 6-month-old catheter with the mentioned complaint.Anatomical insertion site of device: peripherally upper arm catheter flow got stuck, technicians have taken back the broken catheter from body.There was a delay in the procedure." 3 devices were reported.Associated mdrs: 9680794-2025-00542, 9680794-2025-00540 and 9680794-2025-00541.
Event or Problem Description
It was reported that "catheter kinking and breakage issue reported from cvad department.The department have shared images of 6-month-old catheter with the mentioned complaint.Anatomical insertion site of device: peripherally upper arm catheter flow got stuck, technicians have taken back the broken catheter from body.There was a delay in the procedure." 3 devices were reported.Associated mdrs: 9680794-2025-00542 and 9680794-2025-00541.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided six photos for analysis.The first two images show two different pressure injectable (pi) catheters whilst inside the patient.The remaining four images show kinking on the catheter body.A rupture on the catheter body was also observed.The customer was contacted to address the rupture.No clarification was provided after three attempts.A rupture of this type can be a result of kinking along the catheter body in combination with high pressurization; however, as no clarification was provided, the circumstances cannot be verified.Despite the damage observed in the customer images, 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 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 ifu also states, "use only lumen(s) labeled 'pressure injectable' for pressure injection to reduce risk of catheter failure and/or patient complications".The ifu also states, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter".The customer report of kinked catheter was confirmed by visual inspection of the customer supplied photo.Analysis of the photos also revealed evidence of a catheter body rupture.Rupturing of this type can be a result of kinking in combination with high pressurization.Regardless of the observed damage, a full complaint verification testing 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.
Additional Manufacturer Narrative
(b)(4).The customer returned one pressure injectable catheter and lidstock.Signs of use were observed around the distal tip.The distal tip of the catheter appeared to be intentionally cut after the 45-5 marking.No damage, such as kinking, was observed on any portion of the returned sample.The damages observed in photos provided by the customer were not observed on the returned catheter.The length of the catheter measured 17 7/8", which is not within the specification limits of 19 1/2" - 20" per the catheter product drawing.This indicates that approximately 1 5/8" - 2 1/8" of the catheter was trimmed off from the distal end.The outer diameter of the catheter measured 0.0555, which is within the specification limits of 0.054" - 0.057" per the catheter extrusion product drawing.The inner diameter of the catheter extrusion measured 0.035", which is within the specification limits of 0.035" - 0.038" per the catheter extrusion product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit.A lab inventory guidewire measuring 0.0185" was inserted through the catheter.No resistance was encountered, and the guidewire was able to pass completely through the catheter.Performed per ifu statement, "if 80 cm guidewire is used, insert guidewire into distal lumen until soft tip of guidewire extends beyond catheter tip.Advance guidewire/catheter as a unit through peel-away sheath to final indwelling position, while maintaining control of distal end of guidewire." the catheter was flushed with water using a lab inventory syringe.No signs of blockages were observed, and the water flushed out with no resistance.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "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 a kinked catheter was not confirmed through visual inspection of the returned catheter.The customer provided several images showing damage to several catheters from three reported events, however, the damage observed in the photos was not observed on the returned device indicating the damage correlates to the associated events reported.No damage or kinking was observed on the returned sample.The device met all relevant dimensional and functional requirements, and a review of the device history record revealed no relevant findings.Based on these circumstances, the root cause could not be determined as no damage was observed to the returned catheter and based on the discrepancy between the customer photos and returned sample.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
It was reported that "catheter kinking and breakage issue reported from cvad department.The department have shared images of 6 month old catheter with the mentioned complaint.Anatomical insertion site of device: peripherally upper arm catheter flow got stuck, technicians have taken back the broken catheter from body.There was a delay in the procedure." 3 devices were reported.Associated mdrs: 9680794-2025-00542, 9680794-2025-00540 and 9680794-2025-00541.

• Brand Name: ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 22390787
• Report Number: 9680794-2025-00540
• Device Sequence Number: 9401178
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: (01)00801902101051(11)240824(17)260228(10)33F24E0748(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: PR-35041-HPHNM
• Device Lot Number: 33F24E0748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 11/26/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/28/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2024
• 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: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Sex: Male