MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN035619
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: during insertion the physician began advancing the spring wire guide, the "coil blows up" (unraveled) and they removed the entire catheter and wire.Did not pursue inserting central line at the time.There was no injury or harm to the patient as a result of the device, but therapy was delayed.The patient's condition was reported as critical, unrelated to the device.
Additional Manufacturer Narrative
Qn# (b)(4).The customer did not return a complaint sample; however, they supplied two photos showing an unraveled and separated guide wire.The guide wire shows obvious signs of use in the form of biological material.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit states: "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." "clinicians must be aware of potential entrapment of the guidewire by any implanted device in circulatory system.It is recommended that if patient has a circulatory system implant, catheter procedure be done under direct visualization to reduce risk of guidewire entrapment." "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." "warning: do not apply undue force on guidewire to reduce risk of possible breakage." "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guide wire separated was confirmed through examination of the customer supplied photos.The image showed the guide wire unraveled and separated; however, the actual complaint sample was not returned for evaluation.The device history record for the guide wire was reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: during insetion the physician began advancing the spring wire guide, the "coil blows up" (unraveled) and they removed the entire catheter and wire.Did not pursue inserting central line at the time.There was no injury or harm to the patient as a result of the device, but therapy was delayed.The patient's condition was reported as critical, unrelated to the device.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11772901
• Report Number: 1036844-2021-00079
• Device Sequence Number: 19848906
• Product Code: FOZ
• UDI-Device Identifier: 10801902058611
• UDI-Public: 10801902058611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 10/31/2021
• Device Model Number: IPN035619
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F20D0155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 78