MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000260

Device Problem Fluid/Blood Leak (1250)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/01/2023

Event Type  Injury  

Event Description

It was reported that "excessive condensation" was noted in the driveline tubing.As a result, the iab was surgically removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Returned for investigation was a section of a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, only one partial section of the iabc was returned; the section included the outer lumen, central lumen, bladder, and distal tip.The total length of the section was approximately 54.7cm.The end of both the central and outer lumen appeared consistent with being cut.The bladder was noted fully unwrapped.A teflon sheath was noted on the returned iabc; the teflon sheath body/extrusion was noted cut near the teflon sheath hub and the remaining length of the teflon sheath body/extrusion was not returned with the sample.The distal end of the cut sheath was noted at approximately 49.5cm from the iabc distal tip; the teflon sheath hub appeared typical.Bends were noted to the iabc central lumen at approximately 10cm, 31cm, and 45cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc helium pathway.No other components were returned with the sample.The bladder thickness was measured at six points with measurements ranging from 0.0058in-0.0063in and was within specification.Due to the returned state of the device, functional leak testing was unable to be performed.As a result, the bladder was closely inspected.During inspection, abrasions were observed at approximately 4.7cm to 5.6cm from the iabc distal tip.A full thickness abrasion to the bladder was confirmed at approximately 5.1cm and the appearance is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were noted on the iabc.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire was unable to advance through the central lumen at approximately 4.7cm from the iabc distal tip.Some blood was noted on the guidewire.The central lumen was likely blocked by dried blood.The returned device could not be functionally tested further due to the returned state of the device.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint of iab blood in helium pathway is confirmed.Only a partial section of the iabc was returned for investigation and blood was noted within the helium pathway.During the investigation, the intra-aortic balloon catheter (iabc) bladder had a full thickness abrasion, which likely caused the complaint and caused 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.

Event Description

It was reported that "excessive condensation" was noted in the driveline tubing.As a result, the iab was surgically removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16826294
• MDR Text Key: 314122127
• Report Number: 3010532612-2023-00225
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.
• Patient Sex: Female
• Patient Weight: 72 KG