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

Catalog Number IAB-S840C

Device Problem Material Twisted/Bent (2981)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported that "the patient was admitted to the hospital with acute myocardial infarction.After inserting an iabp balloon catheter on the left side, catheter kink was found, and the catheter was immediately withdrawn and replaced with a new one".The 2nd catheter was inserted at a different insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The reported complaint of "catheter kink" 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 patient was admitted to the hospital with acute myocardial infarction.After inserting an iabp balloon catheter on the left side, catheter kink was found, and the catheter was immediately withdrawn and replaced with a new one".The 2nd catheter was inserted at a different insertion site.No patient harm or injury.The patient status is reported as "fine".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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17541242
• MDR Text Key: 321078926
• Report Number: 3010532612-2023-00438
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: 10801902161977
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22L0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: N/A.; N/A.