MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN915325

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/31/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that "during use, sudden bleeding from the catheter introducer with evidence of introducer rupture." additional information states that the catheter was removed and a 2nd catheter was inserted at a different insertion site.There was no harm or injury to the patient.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.

Event Description

It was reported that "during use, sudden bleeding from the catheter introducer with evidence of introducer rupture." additional information states that the catheter was removed and a 2nd catheter was inserted at a different insertion site.There was no harm or injury to the patient.The patient status is reported as "fine".

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• 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: 16388655
• MDR Text Key: 309728296
• Report Number: 3010532612-2023-00103
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: 10801902161977
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN915325
• Device Catalogue Number: IAB-S840C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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