MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC KIT: 1L 4.5FR 55CM AGBA TIPTRACK; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45541-TTS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: after the peel away sheath was placed, the rn was unable to remove the peel away sheath without retracing the sheath a bit.Once retracted , the guidewire was removed and noted to be bent.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer returned one guide wire for analysis.Signs of use were observed on the wire.The kink/bend in the guide wire was located 39.5cm via calibrated ruler from the distal tip.The overall length of the guide wire measured 45cm via calibrated ruler which was within the specification of 43.75cm - 46.25cm per guide wire product drawing.The outer diameter (od) of the guide wire measured 0.0180" via calibrated micrometer which was within the specification of 0.0160-0.0185" per measurement in the guide wire product drawing.The returned guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states, "advance guidewire into introducer needle." the guide wire was advanced through a lab inventory 21ga introducer needle to functionally test the guide wire.The guide wire passed through the needle with minimal resistance.A manual tug test confirmed that the distal weld was intact.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." a device history record review was performed on the guide wire and no relevant manufacturing issues were identified.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 that: after the peel away sheath was placed, the rn was unable to remove the peel away sheath without retracing the sheath a bit.Once retracted , the guidewire was removed and noted to be bent.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: ARROW PI PICC KIT: 1L 4.5FR 55CM AGBA TIPTRACK
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18381936
• Report Number: 9680794-2023-01018
• Device Sequence Number: 12712204
• Product Code: LJS
• UDI-Device Identifier: 30801902125379
• UDI-Public: 30801902125379
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 11/30/2024
• Device Catalogue Number: CDC-45541-TTS
• Device Lot Number: 33F23G0323
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown