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

Catalog Number	SI-11142
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the dilator deformed during use.Another kit was opened to complete the case.There was no reported patient harm or consequence.
Event or Problem Description
It was reported that: the dilator deformed during use.Another kit was opened to complete the case.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned multiple components from a psi kit.The dilator will be analyzed as part of this complaint investigation.No definite signs of use were observed.Visual analysis did not reveal any defects or anomalies on the returned dilator nor any of the other components.The length from the hub to the distal tip measured 8 1/8", which is within the specification limits of 8 1/32"-8 9/32" per the dilator product drawing.The dilator outer diameter measured 3.03mm, which is within the specification limits of 2.97mm-3.05mm per the dilator extrusion product.The dilator inner diameter at the proximal end measured 1.3208mm, which is within the specification limits of 1.30mm-1.40mm per the dilator extrusion product.The returned guide wire was inserted through the dilator tip.Little to no resistance was observed as the guide wire passed completely through the dilator.Performed per ifu statement, "thread tapered tip of dilator/access device assembly over guidewire.Sufficient guidewire length must remain exposed at hub end of device to maintain a firm grip on guidewire".The dilator was then inserted through the mac catheter.Little to no resistance was encountered as the dilator passed.The dilator hub was able to securely fit into the cap of the hemostasis valve.Performed per ifu statement , "insert entire length of dilator through hemostasis valve into access device pressing hub of dilator firmly into hub of hemostasis valve assembly.Place assembly on sterile field awaiting final placement".A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing guidewire, dilator, or access device.Excessive force can cause component damage or breakage.Precaution: do not withdraw dilator until the access device is well within the vessel to reduce the risk of damaging tip." the report of a damaged dilator body/hub was not able to be confirmed through complaint investigation.The returned dilator met all relevant visual, dimensional, and functional requirements.A device history record review was performed with no relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the dilator deformed during use.Another kit was opened to complete the case.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).The customer returned multiple components from a psi kit.The dilator will be analyzed as part of this complaint investigation.No definite signs of use were observed.Visual analysis did not reveal any defects or anomalies on the returned dilator nor any of the other components.The length from the hub to the distal tip measured 8 1/8", which is within the specification limits of 8 1/32"-8 9/32" per the dilator product drawing.The dilator outer diameter measured 3.03mm, which is within the specification limits of 2.97mm-3.05mm per the dilator extrusion product.The dilator inner diameter at the proximal end measured 1.3208mm, which is within the specification limits of 1.30mm-1.40mm per the dilator extrusion product.The returned guide wire was inserted through the dilator tip.Little to no resistance was observed as the guide wire passed completely through the dilator.Performed per ifu statement, "thread tapered tip of dilator/access device assembly over guidewire.Sufficient guidewire length must remain exposed at hub end of device to maintain a firm grip on guidewire".The dilator was then inserted through the mac catheter.Little to no resistance was encountered as the dilator passed.The dilator hub was able to securely fit into the cap of the hemostasis valve.Performed per ifu statement, "insert entire length of dilator through hemostasis valve into access device pressing hub of dilator firmly into hub of hemostasis valve assembly.Place assembly on sterile field awaiting final placement".A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing guidewire, dilator, or access device.Excessive force can cause component damage or breakage.Precaution: do not withdraw dilator until the access device is well within the vessel to reduce the risk of damaging tip." the report of a damaged dilator body/hub was not able to be confirmed through complaint investigation.The returned dilator met all relevant visual, dimensional, and functional requirements.A device history record review was performed with no relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• 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: angela meister ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18129867
• Report Number: 3006425876-2023-01071
• Device Sequence Number: 7581146
• Product Code: FOZ
• UDI-Device Identifier: 00801902102898
• UDI-Public: (01)00801902102898(11)220406(17)260328(10)71F22D0102(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): 10/17/2023

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 Expiration Date: 03/28/2026
• Device Catalogue Number: SI-11142
• Device Lot Number: 71F22D0102
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/05/2023; Not provided
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/05/2023; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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