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

Catalog Number IAB-06840-U

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that "the patient had acute inferior myocardial infarction and the balloon counterpulsation was good after femoral a rtery puncture.About half an hour later, blood and liquid appeared inside the balloon.The same situation was observed when replacing the second set.After withdrawing the balloon, it was found that there were cracks in the front end of two sets of balloons and a small hole in the middle of one set of balloons".The 2nd iab was inserted in the same insertion site.A 3rd iab was not inserted.No patient harm or injury.The patient status is reported as "fine".Please see associated mdr #3010532612-2023-00669.

Manufacturer Narrative

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

Event Description

It was reported that "the patient had acute inferior myocardial infarction and the balloon counterpulsation was good after femoral artery puncture.About half an hour later, blood and liquid appeared inside the balloon.The same situation was observed when replacing the second set.After withdrawing the balloon, it was found that there were cracks in the front end of two sets of balloons and a small hole in the middle of one set of balloons".The 2nd iab was inserted in the same insertion site.A 3rd iab was not inserted.No patient harm or injury.The patient status is reported as "fine".Please see associated mdr #3010532612-2023-00669.

Manufacturer Narrative

(b)(4).No serial number was reported.The serial number on the returned sample is fl30144.The lot number (18f23f0003) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the iabc central/outer lumen was noted at approximately 51.4cm from the iabc distal tip.Spots of dried blood were noted on the exterior surfaces of the returned iabc.Some traces of dried blood were noted within the iabc short driveline tubing; the catheter was likely cleaned prior to return.No other visual damage or abnormalities were noted.The bladder thickness was measured at six points with measurements ranging from 0.0053in-0.0062in and was within specification of process document.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 iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested and two (2) leaks were immediately noticeable from the bladder membrane.Under microscopic inspection, the leak sites are consistent with contact from a sharp object and were noted at approximately 9.8cm and 11cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 51.5cm from the iabc distal tip, which is the location of the previously noted bend.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.Resistance was noted at approximately 30.4cm from the iabc luer, which is the location of the previously noted bend.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 with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that "blood and liquid appeared inside the balloon" is confirmed.During the investigation, two punctures consistent with contact from a sharp object were found on the iabc bladder , which caused 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 bladder leaks.The root cause of the bladder leaks is undetermined.The most probable potential cause of how the catheter came into contact with a sharp object is customer handling.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 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: 18255835
• MDR Text Key: 329593076
• Report Number: 3010532612-2023-00667
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23F0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male