MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	SI-11142
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that wire bented.So md opened up the new kit to finish the procedure.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that wire bented.So md opend up the new kit to finish the procedure.".
Additional Manufacturer Narrative
Qn# (b)(4).The report that the spring wire guide was kinked was confirmed through examination of the returned sample.The customer returned multiple components of a mac kit, including one guide wire assembly, arrow raulerson syringe (ars), needle, and dilator, for analysis.Signs of use in the form of biomaterial were observed on the returned components, which indicates that the damage may have occurred during handling of the sample.Visual analysis revealed that the returned guide wire contained two kinks towards the distal end.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kinks on the guide wire measured 393mm and 411mm via calibrated ruler from the proximal end.The guide wire total length measured 456mm via calibrated ruler, which was not within the specification limits of 450-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.849mm via calibrated micrometer, which was within the specification limits of 0.838-0.877mm per the guide wire product drawing.The returned swg was functionally tested per the instructions for use (ifu)provided with this kit states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The undamaged portions of the wire passed through the returned ars / 18ga needle subassembly with little to no resistance.A manual tug test confirmed the distal and proximal welds were secure.A device history record review was performed on the reported finished good, and no relevant findings were identified.During full assembly, the kink on the guide wire would have been located within the protective tubing of the advancer assembly.Based on the customer report and sample received, the potential root cannot be be determined as it could not be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that wire bented.So md opend up the new kit to finish the procedure.".

• Brand Name: ARROW MULTILUMEN/PSI SET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 18245362
• Report Number: 3006425876-2023-01160
• Device Sequence Number: 15114332
• Product Code: FOZ
• UDI-Device Identifier: 00801902102898
• UDI-Public: (01)00801902102898(11)230313(17)270528(10)71F23C0317(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: SI-11142
• Device Lot Number: 71F23C0317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/20/2023; Not provided
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/22/2023; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown