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

Catalog Number IAB-06830-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  

Manufacturer Narrative

Qn# (b)(4).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 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 #3010532612-2023-00667.

Manufacturer Narrative

(b)(4).No serial number was reported.The serial number on the returned sample is gk30506.The reported lot number (18f23g0051) 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.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 5.1cm from the iabc distal tip.The iabc central lumen within the flex-tip assembly area was noted damaged; the wire round/polyimide (part of the flex tip assembly) was noted unraveled at approximately 5.7cm from the iabc distal tip and the polyimide (part of the flex tip assembly) was noted damaged.Dried blood was noted on the exterior surfaces of the returned sample.Some traces of dried blood were noted within the helium pathway; the catheter was likely cleaned prior to return.The bladder thickness was measured at six points with measurements ranging from 0.0055in-0.0063in 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 catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No debris was noted.The iabc was leak tested and a leak was immediately detected from the iabc distal tip.The leak from the iabc distal tip is consistent with the previously confirmed damaged central lumen.The iabc was leak tested again with the iabc distal tip blocked off; another leak was immediately detected from the iabc luer.The leak from the iabc luer is consistent with the previously confirmed damaged central lumen.The iabc was leak tested again with the distal tip and luer end blocked off; no other leaks were detected.Additionally, an abnormality occurred to the iabc bladder during the investigation.Initially, the bladder inflated fully and without abnormality, but a section of the bladder immediately become enlarged during the leak test; the enlarged section was at approximately 17.2cm to 22.5cm from the iabc distal tip.Dimensional testing was performed on the enlarged area; the bladder thickness was measured along the enlarged area with measurements ranging from 0.0015in-0.0041in.The cause of the enlarged bladder could not be determined.No damage or abnormality was noted during the visual inspection and initial inflation of the bladder.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted.The guidewire was able to advance through the central lumen.No blood 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 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 for iab blood in helium pathway is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted damaged within the iabc flex-tip assembly area.The damaged central lumen could result in blood entering the helium pathway.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 damaged central lumen.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.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 #3010532612-2023-00667.

• 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: 18255831
• MDR Text Key: 329592866
• Report Number: 3010532612-2023-00669
• 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-06830-U
• Device Lot Number: 18F23G0051
• 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: 07/26/2023
• 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