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

Catalog Number IAB-S840C

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that "the connector was missing the o-rings and didn't work properly - gas leakage alarm.And there was some struggle with the guide wire: it didn't pass smoothly".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #3010532612-2023-00700.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information received on 14 dec 2023 states that "the failure of the sealing rings was noted during use of the device, when the device started to alarm.There was no harm to the patient, as we exchanged the product immediately".The information further notes "another catheter was used, due to the failure of the first one.Insertion was performed via the femoral artery".The reported complaint for helium loss alarm was confirmed based on the customer photos provided with the complaint report.The photo identified both o-rings missing from the inflation driveline tubing, which could result in a helium loss alarm.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the missing o-rings.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "the connector was missing the o-rings and didn't work properly - gas leakage alarm.And there was some struggle with the guide wire: it didn't pass smoothly".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #3010532612-2023-00700.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18320861
• MDR Text Key: 330402991
• Report Number: 3010532612-2023-00702
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 18F22K0028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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