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

Catalog Number IAB-06830-U

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "a 30cc arrow iab catheter connected to maquet cardiosave iabp was placed in the patient on (b)(6) 2024, the helium driveline tubing was discovered to be filled with blood on the same day, as mentioned by the user.The alleged catheter was removed".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4), returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the distal end of the teflon sheath was at approximately 41.2cm from the iabc distal tip; clear liquid was noted within the sheath sidearm.The teflon sheath hub was noted connected to the hemostasis cuff.The long arterial pressure tubing was noted connected to the iabc luer.The one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.Bends to the iabc were noted at approximately 4.1cm, 28.1cm, and 61.4cm from the iabc distal tip.Damage was noted to the outer lumen consistent with being pinched or crushed at approximately 23.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The returned iabc likely cleaned prior to the return.The bladder thickness was measured at six points with measurements ranging from 0.0056in-0.0065in and was within specification.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.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested and a leak was immediately detected from the bladder membrane near the proximal end.The leak site was noted at approximately 23.6cm to 23.8cm from the iabc distal tip.During further inspection, the leak site is consistent with contact from a damaged outer lumen.Upon microscopic inspection, the outer lumen was noted damaged near the area of the bladder leak site, and it was consistent with being crushed or pinched.No other leaks were detected during functional testing.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that "helium driveline tubing was discovered to be filled with blood" is confirmed.During the investigation, a puncture to the bladder, consistent with contact from a damaged outer lumen , caused the reported complaint and can cause blood to enter the helium pathway.No other leaks were detected during 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 due to the bladder leak.The root cause of the complaint is undetermined.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that "a 30cc arrow iab catheter connected to maquet cardiosave iabp was placed in the patient on (b)(6) 2024, the helium driveline tubing was discovered to be filled with blood on the same day, as mentioned by the user.The alleged catheter was removed".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• 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: 18681355
• MDR Text Key: 335046711
• Report Number: 3010532612-2024-00120
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22H0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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