MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC MICRO INTRODUCER SET; WIRE, GUIDE, CATHETER

Catalog Number	MP-04450-AS
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "doctors were attempting to place a new hd tunnel catheter in a patient and when using the sizing kit the micro introducer wire , frayed and broke in the patient , resulting in a piece left in the patient, requiring the patient to go to the or for retrieval and then cath placement." the patient was reported as fine post the procedure.
Event or Problem Description
It was reported that: "doctors were attempting to place a new hd tunnel catheter in a patient and when using the sizing kit the micro introducer wire, frayed and broke in the patient, resulting in a piece left in the patient, requiring the patient to go to the or for retrieval and then cath placement." the patient was reported as fine post the procedure.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire and lidstock for investigation.No definite signs of use were observed.Visual analysis revealed that the guidewire had become unraveled and separated towards the distal end.One kink was observed in the solid proximal portion of the guidewire.Microscopic examination confirmed the damage and revealed that the core wire separated near the distal end.The separated portion of the guide wire was not returned.The proximal end was still intact.The kink measured at 10cm from the proximal end.The total length of the returned core wire measured to be 42cm which is not within the specification limits of 44.9cm-45.1cm per the guide wire graphic.This indicates that approximately 3cm of the wire was separated and not returned for investigation.The guide wire outer diameter measured 0.0185", which is within the specification limits of 0.0175"-0.0185" per the swg graphic.Functional inspection was performed on the undamaged proximal portion of the returned guidewire.The functional testing was performed per the ifu provided with the kit states, "insert floppy tip of guidewire through introducer needle into vein.Advance guidewire to desired catheter tip location.".The guidewire portion was inserted through a lab inventory introducer needle with slight resistance at the site of the kink.No other defects or anomalies were identified.A manual tug test was performed on the proximal end of the wire.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 customer report that the guidewire separated during use was confirmed through examination of the returned sample.The guidewire was observed to be unraveled and separated towards the distal end.Dimensional and functional testing did not reveal any defects or anomalies that would be indicative of a manufacturing related issue.A device history record review was performed, and no relevant findings were identified.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guidewire breakage may occur if a force greater than the design specification is applied during removal.Based on the condition of the guidewire and the report that the damage was observed during treatment, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.4.- unique identifier (udi) # corrected to (b)(4).

• Brand Name: MICRO INTRODUCER SET
• Common Device Name: WIRE, GUIDE, 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: 19537305
• Report Number: 9680794-2024-00566
• Device Sequence Number: 18227103
• Product Code: DQX
• UDI-Device Identifier: 00801902037756
• UDI-Public: 00801902037756
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• 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): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MP-04450-AS
• Device Lot Number: 14F23J0149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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.
• Patient Sex: Unknown