MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 4 FR 60CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07121

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that "when the user was inserting the balloon catheter into a guiding catheter, the balloon was stuck in a guiding catheter.Therefore, the balloon catheter was removed and replaced with a new one to complete the procedure without problem.No injury to the patient occurred".

• Brand Name: CATH PKGD: WEDGE 4 FR 60CM
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18897171
• MDR Text Key: 337743452
• Report Number: 3010532612-2024-00206
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002822
• UDI-Public: 00801902002822
• 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
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07121
• Device Lot Number: 16F23G0048
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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