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

Model Number	IPN917531
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Ischemia (1942); Insufficient Information (4580)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that " iab originally inserted in another hospital.Balloon was removed at our hospital.It was difficult for the cardiac surgeon when removing the balloon: balloon was blocked in the stent".Additional information received states "the balloon was removed following acute limb ischemia.Due to the difficulties encountered during removal, the iab + stent had to be removed as a single unit.During the incident, the patient had to be compressed for 30 to 45 minutes after removal".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(6).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that " iab originally inserted in another hospital.Balloon was removed at our hospital.It was difficult for the cardiac surgeon when removing the balloon: balloon was blocked in the stent".Additional information received states "the balloon was removed following acute limb ischemia.Due to the difficulties encountered during removal, the iab + stent had to be removed as a single unit.During the incident, the patient had to be compressed for 30 to 45 minutes after removal".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Additional information received on 20 nov 2023 states that placement of the iab caused limb ischemia in the patient.The patient received "approximately 3-4 hours" of iabp therapy before the iab was removed.Manual compression of the insertion site was required after removal because "impossible to remove the balloon independently of the sheath, the surgeon had to remove the whole assembly (balloon + sheath)".The product was not returned for investigation.The customer photo submitted was reviewed; the photo showed the intra-aortic balloon catheter (iabc) bladder withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion.The issue reviewed in the photo is consistent with the reported complaint.Based on the customer photo, the iabc was not removed from the patient per the instructions for use (ifu).The instructions for use states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." 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 for iab removal difficulty is confirmed based on the customer photo provided with the complaint report.The intra-aortic balloon catheter (iabc) bladder was withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion, which indicates the iabc was not removed from the patient per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The product was not returned for investigation.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 removal difficulty.The probable root cause of the complaint is user related.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported that " iab originally inserted in another hospital.Balloon was removed at our hospital.It was difficult for the cardiac surgeon when removing the balloon: balloon was blocked in the stent".Additional information received states "the balloon was removed following acute limb ischemia.Due to the difficulties encountered during removal, the iab + stent had to be removed as a single unit.During the incident, the patient had to be compressed for 30 to 45 minutes after removal".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The product was not returned for investigation.The customer photo submitted was reviewed; the photo showed the intra-aortic balloon catheter (iabc) bladder withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion.The issue reviewed in the photo is consistent with the reported complaint.Based on the customer photo, the iabc was not removed from the patient per the instructions for use (ifu).The instructions for use states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." 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 for iab removal difficulty is confirmed based on the customer photo provided with the complaint report.The intra-aortic balloon catheter (iabc) bladder was withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion, which indicates the iabc was not removed from the patient per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The product was not returned for investigation.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 removal difficulty.The probable root cause of the complaint is user related.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a, corrected data: n/a.
Event or Problem Description
It was reported that " iab originally inserted in another hospital.Balloon was removed at our hospital.It was difficult for the cardiac surgeon when removing the balloon: balloon was blocked in the stent".Additional information received states "the balloon was removed following acute limb ischemia.Due to the difficulties encountered during removal, the iab + stent had to be removed as a single unit.During the incident, the patient had to be compressed for 30 to 45 minutes after removal".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).In section d provided the full udi # udi related data quality updates only.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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17922958
• Report Number: 3010532612-2023-00583
• Device Sequence Number: 20528776
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)211206(17)231130(10)18F21M0010(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2023

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: 11/30/2023
• Device Model Number: IPN917531
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21M0010
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 11/14/2023; Not provided
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/15/2023; 11/20/2023; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.; N/A.
• Patient Sex: Unknown