MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 18GA X 6"; WIRE, GUIDE, CATHETER

Model Number	IPN033588
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
Physician reports the catheter is kinking during insertion and is softer than usual.The device was replaced.No patient harm reported.
Event or Problem Description
Physician reports the catheter is kinking during insertion and is softer than usual.The device was replaced.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied two photos showing an arterial catheter.Visual analysis revealed that the catheter appears slightly bent/kinked; however, this cannot be officially confirmed due to the quality of the photos.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "care should be exercised that the catheter is not inadvertently kinked at the hub area when securing catheter to the patient as this may result in catheter damage, breakage and loss of arterial monitoring capabilities.Do not apply tape, staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow, or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations." the report that the arterial catheter became kinked could not be officially confirmed through examination of the customer supplied photos.The images show that the arterial catheter was slightly bent; however, it cannot be officially confirmed if a kink was present due to the quality of the photos.A device history record review was performed, and no relevant findings were identified.The probable cause of the catheter kinking could not be determined from the supplied photos, and without the actual sample returned for analysis.Teleflex will continue to monitor and trend for exports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 6"
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11697335
• Report Number: 9680794-2021-00157
• Device Sequence Number: 2936060
• Product Code: DQX
• UDI-Device Identifier: 00801902101563
• UDI-Public: 00801902101563
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 07/31/2024
• Device Model Number: IPN033588
• Device Catalogue Number: SA-04018
• Device Lot Number: 13F19G0713
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1