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

Catalog Number IAB-S840C

Device Problem Defective Device (2588)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion of the iab, "normal puncture, catheter vacuum extraction, it was difficult to remove from the packing.After pull out from the package, it was found that the catheter was not completely curled and could not be inserted.After vacuuming again, it was found that it was still not well curled and could not be insertion".Additional information states that "not completely curled" meant "the catheter was found lose".As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that during insertion of the iab, "normal puncture, catheter vacuum extraction, it was difficult to remove from the packing.After pull out from the package, it was found that the catheter was not completely curled and could not be inserted.After vacuuming again, it was found that it was still not well curled and could not be insertion".Additional information states that "not completely curled" meant "the catheter was found lose".As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint that the iab unwrapped prematurely was not able to be confirmed as 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 was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 17723143
• MDR Text Key: 323113191
• Report Number: 3010532612-2023-00521
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22A0032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 67 KG