MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW DRAINAGE SET; CATHETER IRRIGATION

Catalog Number	AI-01600
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "they opened the item, but the introducer guidewire was faulty, and they could not use the specific wire , because they couldn't gain access into cavity." additional information received reports the guidewire was kinked.The device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).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 complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "they opened the item, but the introducer guidewire was faulty, and they could not use the specific wire , because they couldn't gain access into cavity." additional information received reports the guidewire was kinked.The device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, opened drainage kit including one guide wire within its advancer, an arrow raulerson syringe (ars), and a few more components for analysis.Signs of use were observed on the guide wire.The guide wire was observed to have several bends throughout the body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The major kinks in the guide wire were located at 334mm, 442mm, and 576mm from the proximal tip.Slight bends were measured at 18mm and 648mm from the proximal tip.The overall length of the guide wire measured 681 mm, which is within the specification limits of 679-687 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.85 mm, which is within the specification limits of 0.838-0.877mm per guide wire product drawing.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The undamaged portions of the guide wire passed through both components with little to no resistance.Resistance was observed at the location of the major kinks.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "using the two-piece arrow advancer, advance guidewire through syringe into cavity.If the guidewire does not initially advance with ease, the needle may not be placed properly within the cavity." it also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guide wire kinked during use was confirmed through complaint investigation of the returned sample.The guide wire had several kinks towards the distal tip.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, 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 "they opened the item, but the introducer guidewire was faulty, and they could not use the specific wire , because they couldn't gain access into cavity." additional information received reports the guidewire was kinked.The device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW DRAINAGE SET
• Common Device Name: CATHETER IRRIGATION
• 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: 20127444
• Report Number: 9680794-2024-00861
• Device Sequence Number: 11538583
• Product Code: GBX
• UDI-Device Identifier: 00801902097903
• UDI-Public: (01)00801902097903(11)230713(17)280630(10)33F23G0003(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K895516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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 Catalogue Number: AI-01600
• Device Lot Number: 33F23G0003
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 11/27/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/04/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown