MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE GUIDE CATHETER

Model Number IPN035912

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Associated mdr#s for the two devices reported: 9680794-2023-00446.

Event Description

Physician reported the catheter was not flushing during patient use.The catheter was removed and replaced.No patient harm was reported.The patient's condition is reported as fine.Additional information received 05jun2023 reported the issue occurred with two devices and a third catheter was successfully placed without futher incident.

Manufacturer Narrative

Qn#(b)(4).The customer report of catheter blocked was not confirmed by visual inspection of the customer supplied photos as only images of the product lidstock were provided.However, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "warning: 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." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Physician reported the catheter was not flushing during patient use.The catheter was removed and replaced.No patient harm was reported.The patient's condition is reported as fine.Additional information received 05jun2023 reported the issue occurred with two devices and a third catheter was successfully placed without further incident.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Type of Device: WIRE GUIDE CATHETER
• 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: 17148330
• MDR Text Key: 317860596
• Report Number: 9680794-2023-00480
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: 00801902002730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN035912
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F23B0058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED