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

Model Number IPN030318

Device Problem Material Separation (1562)

Patient Problem Inflammation (1932)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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 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.

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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11258710
• MDR Text Key: 229865419
• Report Number: 3006425876-2021-00101
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902102775
• UDI-Public: 00801902102775
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN030318
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F20D0641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1