MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM; CATHETER, PERCUTANEOUS

Model Number	IPN030318
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the physician tried to pass the guidewire through the introducer needle and it "got stuck".At the third attempt to introduce the catheter in the patient's arm the guidewire "breaks and fractures".The physician withdrew the guidewire and introducer needle.It was reported the patient had "multiple punction at the skin and local inflammation".No medical intervention was required.Another device was placed without problem.The patient's condition was reported as "critical" unrelated to the device issue.
Event or Problem Description
The complaint is reported as: the physician tried to pass the guidewire through the introducer needle and it "got stuck".At the third attempt to introduce the catheter in the patient's arm the guidewire "breaks and fractures".The physician withdrew the guidewire and introducer needle.It was reported the patient had "multiple punction at the skin and local inflammation".No medical intervention was required.Another device was placed without problem.The patient's condition was reported as "critical" unrelated to the device issue.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 8CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11258710
• Report Number: 3006425876-2021-00101
• Device Sequence Number: 3381911
• Product Code: DQY
• UDI-Device Identifier: 00801902102775
• UDI-Public: 00801902102775
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 03/14/2025
• Device Model Number: IPN030318
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F20D0641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1