MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL; INTRODUCER CATHETER

Model Number	IPN036452
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported issue with guidewire "fraying or shredding" during removal.It was reported the doctor was able to clamp the wire and remove it before it broke.No patient harm was reported.It was reported there were two devices with this issue, one right after the first.
Additional Manufacturer Narrative
(b)(4), the customer returned an unopened psi kit for analysis.Since the customer reported that the defect was found during use, it is being assumed that the returned sample is a representative sample.The kit was opened to analyze the sample.Visual analysis revealed no obvious defects or anomalies on any of the kit components.The overall length of the guide wire measured 457mm, which is within the specification limits of 450mm-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.843mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The guide wire was threaded through the returned catheter, arrow raulerson syringe (ars), and introducer needle per the instructions for use (ifu).The ifu states, "advance spring-wire guide into syringe approximately 10 cm until it passes through syringe valves".The guide wire passed through all components with little to no resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed and no relevant manufacturing issues were identified.The ifu provided with this kit informs the user, "warning: do not apply excessive force in removing guide wire, dilator, or sheath." the report of a kinked guide wire could not be confirmed through complaint investigation.The customer returned one, unopened representative kit for analysis.Visual analysis of the guide wire did not reveal any defects or anomalies.Additionally, the guide wire met all relevant dimensional and functional requirements , and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported issue with guidewire "fraying or shredding" during removal.It was reported the doctor was able to clamp the wire and remove it before it broke.No patient harm was reported.It was reported there were two devices with this issue, one right after the first.

• Brand Name: ARROW PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL
• Common Device Name: INTRODUCER 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: 15342525
• Report Number: 9680794-2022-00541
• Device Sequence Number: 5037981
• Product Code: DYB
• UDI-Device Identifier: 50801902117019
• UDI-Public: 50801902117019
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K940079
• 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): 08/10/2022

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 Expiration Date: 09/30/2023
• Device Model Number: IPN036452
• Device Catalogue Number: CDC-29803-1A
• Device Lot Number: 13F21M0101
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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
• Patient Sex: Unknown