MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07126

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the user inserted the catheter from the groin and advanced it to around the renal artery.However, the catheter could not be advanced further.Therefore, the catheter was removed and replaced with another manufacturer's product to complete the procedure without problem.No injury to the patient occurred".The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint that the "catheter could not be advanced further" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

Event Description

It was reported that "the user inserted the catheter from the groin and advanced it to around the renal artery.However, the catheter could not be advanced further.Therefore, the catheter was removed and replaced with another manufacturer's product to complete the procedure without problem.No injury to the patient occurred".The patient status is reported as "fine".

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17922504
• MDR Text Key: 326254228
• Report Number: 3010532612-2023-00582
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22L0065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1