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	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "iab rupture".The report states, "pump alarmed helium loss, nurse noted blood in the driveline.Within 25 minutes resident removed iab in the icu.When the resident was removing the iab he met resistance and continued to pull the iab.The iab was stuck in sheath both removed together forcefully.Held pressure on site for 45 min.Noted a cold lower extremity.Brought patient to or for vascular surgery who performed a thrombectomy.Thrombectomy successful but patient still remains in intensive care.The iab was placed on the july 18 and ruptured occurred july 19.A lot of calcification noted by ct surgeon in surgery notes.Iab functioned through the night with no alarms when it was placed on july 18".See associated mdr # 3010532612-2024-00707.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).After review, it has been determined that this complaint was created in error and is a duplicate.Please see mdr #3010532612-2024-00707.Therefore, the initial mdr submitted on 27 august 2024 should be retracted.
Event or Problem Description
Reported as "iab rupture".The report states, "pump alarmed helium loss, nurse noted blood in the driveline.Within 25 minutes resident removed iab in the icu.When the resident was removing the iab he met resistance and continued to pull the iab.The iab was stuck in sheath both removed together forcefully.Held pressure on site for 45 min.Noted a cold lower extremity.Brought patient to or for vascular surgery who performed a thrombectomy.Thrombectomy successful but patient still remains in intensive care.The iab was placed on the july 18 and ruptured occurred july 19.A lot of calcification noted by ct surgeon in surgery notes.Iab functioned through the night with no alarms when it was placed on july 18".See associated mdr # 3010532612-2024-00707.

• 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: 20078383
• Report Number: 3010532612-2024-00706
• Device Sequence Number: 7663398
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)230831(17)250731(10)18F23H0060(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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: 07/31/2025
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F23H0060
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 29 KG