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

Catalog Number	IAB-05830-LWS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Cardiac Perforation (2513)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medwatch # (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3010532612-2023-00470
• Device Sequence Number: 15127055
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 69 KG