MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 9 FR; INTRODUCER, CATHETER

Model Number	IPN033616
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the insertion of the sheath was without problem.A slight resistance was felt when pulling back the guidewire.It was noticied the guidewrie had unravelled and the sheath and guidewire were immediately removed.No patient harm reported.The patient's condition is fine.
Additional Manufacturer Narrative
(b)(4).The customer returned a psi sheath, dilator, guide wire, and product lidstock for analysis.The guide wire was unraveled.Visual inspection of the returned samples revealed the guide wire was unraveled from the proximal end and was kinked in multiple locations along the body.The core wire distal j-bend was deformed and exposed out of the coil wire.Visual inspection of the sheath and dilator revealed no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The exposed proximal core wire tip is tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.The major kink in the guide wire body was measured at 252mm from the distal tip.The broken core wire measured 453 mm in length, which is within the specification of 450-458mm per guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.841mm which is within the outer diameter specif ication of 0.838-0.877mm per guide wire product drawing.The dilator total length measured 7", which is within the specification of 6 3/4"-7" per the dilator product drawing.The dilator outer diameter measured 0.1183", which is within the specification of 0.117-0.1220" per the dilator product drawing.Functional testing was performed per the instructions for use (ifu) provided with the kit which states, "thread tapered tip of dilator/sheath/valve assembly over spring-wire guide.Grasping near skin, advance assembly with slight twisting motion to a depth sufficient to enter vessel.Dilator may be partially withdrawn to facilitate advancement of sheath through tortuous vessel." the undamaged portions of the guide wire passed through the returned dilator with minimal resistance.A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: do not apply excessive force in remo ving guide wire, dilator or sheath.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire and dilator met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specif ication 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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the insertion of the sheath was without problem.A slight resistance was felt when pulling back the guidewire.It was noticied the guidewrie had unravelled and the sheath and guidewire were immediately removed.No patient harm reported.The patient's condition is fine.

• Brand Name: ARROW PSI SET: 9 FR
• Common Device Name: INTRODUCER, CATHETER
• 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: 14858975
• Report Number: 9680794-2022-00409
• Device Sequence Number: 5158799
• Product Code: DYB
• UDI-Device Identifier: 00801902101709
• UDI-Public: 00801902101709
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 06/30/2026
• Device Model Number: IPN033616
• Device Catalogue Number: SI-09903-E
• Device Lot Number: 14F21F0840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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 Sex: Unknown