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

Model Number IPN000263

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

It was reported that "blood leakage occurred when counterpulsation was started." as a result, the staff changed the catheter.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.The iabc was confirmed with a leak from the outer lumen which allowed blood to enter the helium pathway.The leak site identified is consistent with contact from a sharp object.The root cause of the outer lumen leak is undetermined.The most probable potential cause of how the iab met contact with a sharp object is customer handling.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

Event Description

It was reported that "blood leakage occurred when counterpulsation was started." as a result, the staff changed the catheter.There was no report of patient complications, serious injury or death.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 13793691
• MDR Text Key: 287346810
• Report Number: 3010532612-2022-00058
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F21E0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2021
• 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