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

Catalog Number IAB-06840-U

Device Problem Break (1069)

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

Event Date 12/29/2023

Event Type  malfunction  

Event Description

It was reported that "the pmup alarm "1", catheter cannot function properly, remove iabp catheter." patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging that matches the serial number for the returned sample.Upon return, the distal end of the teflon sheath was at approximately 35.4cm from the iabc distal tip.The one-way valve was tethered to the short driveline tubing.The supplied 40cc inflation driveline tubing was connected to the short driveline tubing.The distal end of the bladder was noted wrapped (or considered twisted).Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.The customer supplied photos were reviewed.The first photo shows a fluoroscopy picture of the patient and catheter.The second photo shows a "high pressure (1)" alarm, which matches the reported complaint.The customer supplied video was also reviewed; the video shows the iabc balloon not fully inflating/would not fully unwrap, which is consistent with the reported complaint.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.During the leak test, the bladder did not fully inflate.The body of the bladder had inflated but the distal portion of the bladder would not fully unwrap and was consistent with being twisted.No leaks were detected.The iabc was connected to an iabp using the returned 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.A "high pressure (1)" alarm was triggered after initiating pumping.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 or debris was noted on the guidewire upon removal.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 on the guidewire upon removal.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 "high pressure (1)" alarm is confirmed.During the investigation, the distal portion of the iabc bladder was noted twisted and the bladder would fully inflate or unwrap during functional testing.The twisted bladder triggered the "high pressure (1)" alarm and caused the reported complaint.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 twisted bladder.The probable root cause of the complaint is manufacturing related.A non-conformance has been initiated to further investigate the issue.

Event Description

It was reported that "the pump alarm "1", catheter cannot function properly, remove iabp catheter." patient condition was 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: 18579383
• MDR Text Key: 334202906
• Report Number: 3010532612-2024-00101
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23K0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2023
• 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