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

Catalog Number IAB-06840-U

Device Problem Material Rupture (1546)

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

Event Date 12/29/2023

Event Type  malfunction  

Event Description

The report states " after inserting the catheter, it was found that the balloon catheter had ruptured and could not be used normally." the patient was reported to be "fine".A new device was used to complete the procedure, same insertion site reported.Patient condition reported "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f23f0025) recorded on the complaint report matches the lot number on the returned packaging box and for the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.Returned with the sample was supplied data-scope inflation driveline tubing; the returned data-scope inflation driveline tubing appeared completely sealed and unused.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was loosely wrapped.Two bends to the iabc central lumen were noted at approximately 5.6cm and 55.3cm 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 iabc appeared to have been cleaned prior to return.The bladder thickness was measured at six points with measurements ranging from 0.0059in-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 iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested and numerous leaks were immediately detected from the bladder membrane.Under microscopic inspection, a total of six (6) repeated leak sites consistent with contact from a sharp object were noted around the circumference of the bladder at approximately 6.4cm 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 5.9cm 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 76.5cm 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 the "balloon catheter had ruptured" is confirmed.During the investigation , numerous punctures to the bladder, consistent with contact from a sharp object, were found on the iabc bladder membrane which can cause the reported complaint.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 complaint 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: corrected data:.

Event Description

The report states " after inserting the catheter, it was found that the balloon catheter had ruptured and could not be used normally." the patient was reported to be "fine".A new device was used to complete the procedure, same insertion site reported.Patient condition reported "fine".

• Brand Name: ARROW 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: 18563347
• MDR Text Key: 333503393
• Report Number: 3010532612-2024-00013
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23F0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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