MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problems Needle Stick/Puncture (2462); Cardiac Perforation (2513)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported via a medwatch report that after insertion of the iab, "the tubing started to back-fill with blood; the balloon pump was then removed and a hole was noted in the balloon at that time.When the balloon was removed the femoral artery was torn requiring a vascular surgeon to come in to repair the left femoral artery".Additional information states that "when withdrawing it the team didn't deflate sufficiently and therefore caused the tear in aorta.Patient post-primary repair of (l) common femoral artery and to icu in stable condition." as a result, a 2nd iab was inserted at a different insertion site.

Manufacturer Narrative

(b)(4).The reported complaint that the "tubing started to back-fill with blood and a hole was noted in the balloon" 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 via a medwatch report that after insertion of the iab, "the tubing started to back-fill with blood; the balloon pump was then removed and a hole was noted in the balloon at that time.When the balloon was removed the femoral artery was torn requiring a vascular surgeon to come in to repair the left femoral artery".Additional information states that "when withdrawing it the team didn't deflate sufficiently and therefore caused the tear in aorta.Patient post-primary repair of (l) common femoral artery and to icu in stable condition." as a result, a 2nd iab was inserted at a different insertion site.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• 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: 17567773
• MDR Text Key: 321385334
• Report Number: 3010532612-2023-00470
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21L0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 69 KG