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

Model Number	IPN039778
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the iab was inserted into the femoral artery (unknown if right or left side) and advanced to intended area.Then, the pumping started but the balloon ruptured.As a result, the iab was removed and the same sized iab catheter (iab-06830-u) was inserted at the same insertion site".Patient condition reported as "fine".
Event or Problem Description
It was reported that "the iab was inserted into the femoral artery (unknown if right or left side) and advanced to intended area.Then, the pumping started but the balloon ruptured.As a result, the iab was removed and the same sized iab catheter (iab-06830-u) was inserted at the same insertion site".Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.The lot number (18f22c0019) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Returned with the sample was supplied data-scope inflation driveline tubing; spots of dried blood were noted within the interior surfaces of the returned inflation driveline tubing.Upon return, the distal end of the teflon sheath was at approximately 29.2cm from the iabc distal tip.The one-way valve was tethered to the short driveline tubing.The short arterial pressure tubing was connected to the iabc luer; liquid blood/fluid was noted within the ap tubing.The bladder was fully unwrapped.Two bends to the iabc central lumen were noted at approximately 5.1cm and 59.2cm from the iabc distal tip.Dried yellow media was noted on the hemostasis cuff, cath-guard and bifurcate.Dried blood was noted on the exterior surfaces of the returned iabc.Dried blood was also noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0057in-0.0065in.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.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 leak suspected is confirmed.The intra-aortic balloon catheter (iabc) bladder had a full thickness abrasion, which caused the blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.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 leak.The root cause of the bladder leak is related to patient condition.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: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15893669
• Report Number: 3010532612-2022-00537
• Device Sequence Number: 12067008
• Product Code: DSP
• UDI-Device Identifier: 10801902145618
• UDI-Public: 10801902145618
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/24/2022

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: 02/28/2024
• Device Model Number: IPN039778
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22C0019
• 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: 11/24/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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 Sex: Unknown