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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
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 # 3010532612-2024-00706.
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 # 3010532612-2024-00706.
Additional Manufacturer Narrative
(b)(4).The serial number of the returned sample is (b)(6).Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 30cc 8fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed biohazard bag.Returned with the sample was the supplied 30cc driveline tubing; dried blood was noted in the tubing.Upon return, the one-way valve was tethered and connected to the short driveline tubing.The bladder was fully unwrapped.Upon visual inspection, the iabc distal tip appeared to no longer be attached to the distal portion of the bladder additionally, there was bladder damage near the tip which appeared consistent with a section being torn approximately 71.5cm from the iabc luer.Bends to the iabc central lumen were noted at approximately 9cm, 23cm, 30cm, 32cm, 34,5cm, 50cm, 64cm and 67cm from the iabc luer end.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The fos cable was visually inspected; no damage or abnormalities were noted.No visual fos fiber breaks were noted.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.The cal key was examined, and no damage was noted.The cal key code is "lcs".A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, blood was confirmed within the iabc helium pathway.Upon return, there was a damaged central lumen and the iabc distal tip was no longer attached to the bladder membrane.Additionally, the distal portion of the bladder was noted torn.Due to the combined damages and returned state of the device, it could not be confidently determined which damage occurred first or what initially caused the blood to enter the helium pathway.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the blood in the helium pathway.The root cause of how the blood entered the helium pathway is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20078561
• Report Number: 3010532612-2024-00707
• Device Sequence Number: 18076673
• 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?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• 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: 09/03/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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