MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN038074
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that after the catheter was inserted, the balloon was found to be ruptured.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertions site.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that after the catheter was inserted, the balloon was found to be ruptured.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertions site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of iab "balloon was found ruptured" 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.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a plastic bag.Upon return, the one-way valve was connected and tethered to the short driveline tubing.The stylet was fully inserted with the iabc.The iabc bladder was fully unwrapped; furthermore, the distal end of the bladder was found detached from the iabc distal tip.Some damage to the outer lumen was noted at approximately 30.5cm to 31.8cm from the iabc distal tip; the outer lumen damage was consistent with a flattened appearance.Dried blood was noted on the exterior surfaces of the returned sample.Some dried blood was noted within the helium pathway.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times according to quality system document.The stylet was removed from the iabc central lumen without any difficulty.The catheter's central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.Some blood was noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the distal tip of the bladder membrane.The leak was consistent with the previously confirmed distal end of the bladder not attached to the iabc distal tip.Upon inspection, the iabc distal tip was still fully intact with the central lumen, no tearing was noted to the bladder material and there was a lamination mark on the tip.The iabc was leak tested again, with the distal tip of the bladder clamped off, and no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the injection lumen.No blood or debris was noted.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 leak suspected is confirmed.During the visual inspection, the distal end of the bladder was no longer attached to the iabc distal tip.A leak was noted from the distal end of the intra-aortic balloon catheter (iabc) bladder membrane during the functional testing.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 bladder not attached to the distal tip.The probable root cause of the complaint is manufacturing related.A non-conformance has been initiated to further investigate the issue.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that after the catheter was inserted, the balloon was found to be ruptured.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertions site.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: 17002749
• Report Number: 3010532612-2023-00283
• Device Sequence Number: 6296063
• Product Code: DSP
• UDI-Device Identifier: 00801902136701
• UDI-Public: (01)00801902136701(11)230119(17)241231(10)18F23A0039(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• 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
• Report Date (Section B): 05/04/2023

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: 12/31/2024
• Device Model Number: IPN038074
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23A0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/23/2023; 09/16/2024
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/26/2023; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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: 72 YR
• Patient Sex: Female