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

Model Number	IPN039778
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(6).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "a 30cc arrow iab catheter connected to maquet cardiosave iabp was placed in the patient on (b)(6) 2022 at 1400, the helium driveline tubing was discovered to be filled with blood on (b)(6) 2022 morning, as mentioned by the [customer].Then, the 30cc iab catheter and sheath were removed as a whole from the patient and exchanged for a new set of arrow ultraflex 30cc iab catheter".Further additional information states that the "[customer] confirmed that there was no replacement of the alleged iab catheter into the patient as the patient was fine without iab support.The [physician] also stated that the insertion of the [original] iab catheter was smooth".No report of patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The serial number (ck10270) recorded on the complaint report matches the serial number on the returned sample.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 yellow bio-hazard bag.Returned with the sample was supplied data-scope inflation driveline tubing; liquid blood was noted within the returned inflation driveline tubing.Upon return, the distal end of the teflon sheath was at approximately 36.1cm from the iabc distal tip; clear fluid was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Numerous bends to the iabc central/outer lumen were noted at approximately 6.0cm, 34.7cm and 59.2cm from the iabc distal tip.Spots of dried blood was noted on the exterior surfaces of the returned iabc.Liquid blood/fluid was noted within the helium pathway.The customer pictures were reviewed; the pictures shows that blood is confirmed present within the helium pathway.The findings noted in the pictures are consistent with the reported event.The bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0059in.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 blood in helium pathway 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.
Event or Problem Description
It was reported that "a 30cc arrow iab catheter connected to maquet cardiosave iabp was placed in the patient on 24 sep 2022 at 1400, the helium driveline tubing was discovered to be filled with blood on 25 sep 2022 morning, as mentioned by the [customer].Then, the 30cc iab catheter and sheath were removed as a whole from the patient and exchanged for a new set of arrow ultraflex 30cc iab catheter".Further additional information states that the "[customer] confirmed that there was no replacement of the alleged iab catheter into the patient as the patient was fine without iab support.The [physician] also stated that the insertion of the [original] iab catheter was smooth".No report of patient harm or injury.

• 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: 15625292
• Report Number: 3010532612-2022-00422
• Device Sequence Number: 20379485
• Product Code: DSP
• UDI-Device Identifier: 10801902145618
• UDI-Public: 10801902145618
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 09/26/2022

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: 03/31/2023
• Device Model Number: IPN039778
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F21D0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Sex: Unknown