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

Catalog Number	IAB-05830-LWS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch "the cardiologist inserted the balloon pump, the balloon would not inflate all the way.Needed to use a different balloon without issue".No additional information surrounding this event is available.
Additional Manufacturer Narrative
(b)(4).Medwatch report (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The h10 field has been corrected and now properly shows.Uf/importer report#: (b)(4).The reported complaint for iab "balloon would not inflate all the way" 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.If the product is returned at a later date, a full investigation of the sample will be completed.
Event or Problem Description
It was reported via medwatch "the cardiologist inserted the balloon pump, the balloon would not inflate all the way.Needed to use a different balloon without issue".No additional information surrounding this event is available.

• Brand Name: ARROW 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 20035825
• Report Number: 3010532612-2024-00671
• Device Sequence Number: 6395540
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)230524(17)250430(10)18F23D0024(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F23D0024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown