MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDA-29803-1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on the weekend, we had to put a central line in someone and the guide wire in two of the packs were kinked, one was kinked while inside the patient and the whole thing needed to be removed in order to get it out and they had to go to a different site all together." the patient's current condition is reported as "fine".Associated mdr number: 9680794-2024-00794.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and lidstock for analysis.Signs of use were observed.The dilator was not returned as part of this complaint.Visual analysis revealed that the guide wire was kinked towards the distal j-bend.Other locations of offset coils were also observed.This resulted in the j-bend to be misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The guide wire length measured 456mm, which is within the specification limits of 450mm-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.85mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The guide wire was inserted through a lab inventory 8.5 fr dilator (inner diameter measured 0.063").Minor resistance was encountered at the location of the kinking; however, the guide wire was able to pass.Performed per ifu statement, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".Functional analysis could not be performed on the dilator involved with this complaint as it was not returned.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 sheath/dilator assembly as this can lead to vessel perforation , bleeding, or component damage".The ifu also states, "do not apply excessive force in placing or removing guidewire, dilator, or sheath.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 report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked towards the distal end.The guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any defects or anomalies.The appearance of the damage seems consistent with undue force applied during insertion; however, a full analysis could not be performed on the dilator as it was not returned.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on the weekend, we had to put a central line in someone and the guide wire in two of the packs were kinked, one was kinked while inside the patient and the whole thing needed to be removed in order to get it out and they had to go to a different site all together." the patient's current condition is reported as "fine".Associated mdr number: 9680794-2024-00794.
Additional Manufacturer Narrative
(b)(4).Corrected data: section d.1.-brand name corrected to arrow psi kit: 8.5 fr x 10 cm antimicrobial.Section d.4.-catalog# corrected to cda-29803-1a.Section d.4.-lot# corrected to 33f23c0785.Section d.4.-expiration date corrected to (b)(6) 2025.Section d.4.-udi# corrected to (b)(4).
Event or Problem Description
It was reported "on the weekend, we had to put a central line in someone and the guide wire in two of the packs were kinked, one was kinked while inside the patient and the whole thing needed to be removed in order to get it out and they had to go to a different site all together." the patient's current condition is reported as "fine".Associated mdr number: 9680794-2024-00794.

• Brand Name: ARROW PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 20029139
• Report Number: 9680794-2024-00792
• Device Sequence Number: 7363732
• Product Code: FOZ
• UDI-Device Identifier: 00801902099426
• UDI-Public: (01)00801902099426(11)230516(17)250420(10)33F23C0785(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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 Expiration Date: 04/20/2025
• Device Catalogue Number: CDA-29803-1A
• Device Lot Number: 33F23C0785
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 09/10/2024; Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/11/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown