MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 50CC; System, balloon, intra-aortic and control

Model Number IPN916138

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported as "iab kinked near the tip and balloon would not fully inflate".The report states that a" call direction from the supply specialist in the cath lab, she was given this iab this morning that was inserted yesterday by the [physician] in the cath lab.She was told by the staff that the catheter appeared to be kinked at the tip and would not fully inflate.They observed the balloon under fluoroscopy, and this is how they could see that it was not fully inflating.The [supply specialist] did not know if there were any alarms from the pump nor which pump was used.The [physician] removed this iab and placed a second 5850-lws without difficulty.The second iab functioned as it should and without any issues".The second iab was placed at the same insertion site.No patient injury or consequence.The patient condition is reported as "fine".

Manufacturer Narrative

(b)(4).The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.The lot number (18f22j0037) recorded on the complaint report matches the lot number on the returned original packaging label and for the returned sample.Returned for investigation was a 50cc 8.0fr fos intra-aortic balloon catheter (iabc) with the original packaging label that matches the serial number on the returned sample.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag.Upon return, the distal end of the teflon sheath was noted at approximately 30.6cm from the iabc distal tip; liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was loosely wrapped.A bend to the iabc central lumen was noted at approximately 24.4cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.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 cal key and fos were connected to the iabp without difficulty.The pump displayed the fos status "ck" (cal key), and the alarm "ap fos cal key missing or corrupt", indicating that the cal key was not recognized by the iabp.The cal key was removed and rotated 180 degrees and then reinserted with the same result.The fos cal key was closely inspected, and no abnormalities were noted.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.The fos was connected to the pump, and the iabc was inserted in the "t" tube and pressurized at intervals of 100mmhg, 200mmhg and 300mmhg.Upon testing the returned fos at pressurized intervals, the output ap fos readings were within specifications.The iabc was connected to an iabp using a lab inventory 50cc inflation driveline tubing.The iabc was inserted into the "t" tube and 75mmhg backpressure was applied.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon p ressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.Resistance was noted at approximately 24.6cm 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 57.6cm from the iabc luer end, 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 of "iab kinked near the tip" is not confirmed.No kinks or bends were identified near the iabc distal tip.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action requ ired at this time.Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "iab kinked near the tip and balloon would not fully inflate".The report states that a" call direction from the supply specialist in the cath lab, she was given this iab this morning that was inserted yesterday by the [physician] in the cath lab.She was told by the staff that the catheter appeared to be kinked at the tip and would not fully inflate.They observed the balloon under fluoroscopy, and this is how they could see that it was not fully inflating.The [supply specialist] did not know if there were any alarms from the pump nor which pump was used.The [physician] removed this iab and placed a second 5850-lws without difficulty.The second iab functioned as it should and without any issues".The second iab was placed at the same insertion site.No patient injury or consequence.The patient condition is reported as "fine".

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 50CC
• Type of Device: System, balloon, intra-aortic and control
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16074533
• MDR Text Key: 308236867
• Report Number: 3010532612-2022-00582
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN916138
• Device Catalogue Number: IAB-05850-LWS
• Device Lot Number: 18F22J0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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
• Treatment: N/A.; N/A.
• Patient Sex: Male