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	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the doctor inserted needle and syringe as soon as he started threading the guidewire the guidewire kinked.The device removed entirely, made two attempts, third attempt was successful but therapy got delayed." it was reported there was no harm to the patient due to the device.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2024-00857.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for evaluation.The complaint of a kinked guide wire was able to be confirmed by the photo.The photo displayed kinking on two different guide wires.The needle was not pictured.However, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.The needle was not pictured, and resistance between the guide wire and needle could not be confirmed.Thus, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the doctor inserted needle and syringe as soon as he started threading the guidewire the guidewire kinked.The device removed entirely, made two attempts, third attempt was successful but therapy got delayed." it was reported there was no harm to the patient due to the device.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2024-00857.
Event or Problem Description
It was reported "the doctor inserted needle and syringe as soon as he started threading the guidewire the guidewire kinked.The device removed entirely, made two attempts, third attempt was successful but therapy got delayed." it was reported there was no harm to the patient due to the device.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2024-00857.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis, which shows a kinked guidewire housed within a clear plastic bag.The complaint of guidewire/needle resistance cannot be confirmed as no needle is pictured in the photo.The customer also returned one drainage catheterization set with the guidewire and tissue dilator for analysis.The needle from the reported event was not returned.Obvious deformities were observed on the guidewire.Visual analysis revealed kinking and bending on the guidewire and the j-bend misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.It also revealed the guide wire coil with offset coils in 3 instances.Visual inspection of the needle could not be performed as it was not returned.The major kinks on the guidewire were measured at 129mm, 167mm, 345mm, 357mm, 401mm, 420mm , 472mm, 498mm, 561mm, and 621mm from the proximal end.The guidewire length measured 682mm, which is within the specification limits of 679mm-687mm per the guidewire product drawing.The guidewire outer diameter measured 0.84mm, which is within the specification limits of 0.838mm-0.977mm per the guidewire product drawing.The guidewire was inserted into a lab inventory 18ga introducer needle and lab inventory ars syringe.Significant resistance was encountered at the locations of kinking and offset coils.The guidewire was unable to fully pass through the introducer needle due to the deformities observed throughout.Performed per ifu statement, "attach raulerson syringe to desired 18 ga.Introducer needle" and "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle.Advancement of guidewire through arrow raulerson syringe may require a gentle rotating motion." a manual tug test confirmed that the distal and proximal ends of the coiled section were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit cautions the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report of a damaged guide wire was confirmed through complaint analysis; however, the report of resistance when advancing could not be verified as only the guide wire was returned.The guide wire met all relevant dimensional requirements with no evidence of manufacturing issues.Analysis of the introducer needle could not be performed as it was not returned.Based on the customer report and the sample received, the root cause cannot be determined at this time as the introducer needle was not returned as part of this complaint investigation.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 20146054
• Report Number: 9680794-2024-00858
• Device Sequence Number: 4235505
• Product Code: GBX
• UDI-Device Identifier: 00801902097903
• UDI-Public: (01)00801902097903(11)231025(17)280930(10)33F23K0026(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): 08/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AI-01600
• Device Lot Number: 33F23K0026
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 12/05/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/04/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 100 KG