MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problems Fluid/Blood Leak (1250); Failure to Zero (1683)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

It was reported that "after the staff open the iabp balloon and connect the fos and cal key to the machine, it couldn't be zeroed and recognized by the machine.As a result, the transducer was used." during preliminary investigation of the complaint sample that was returned on (b)(6) 2023, blood was noted inside the helium pathway of the device.No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "after the staff open the iabp balloon and connect the fos and cal key to the machine, it couldn't be zeroed and recognized by the machine.As a result, the transducer was used." during preliminary investigation of the complaint sample that was returned on 13 january 2023, blood was noted inside the helium pathway of the device.No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4) additional information received on 19 jan 2023 states that "as seen in the report, no leakage or rupture were reported, the point of the complaint was fibreoptic not detected".No serial number was reported.The serial number on the returned sample is (b)(6).The reported lot number (18f22a0012) matches the lot number for the returned original packaging box and for the returned sample.Returned for investigation was a 30cc 8.0fr fos intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.Upon return, the distal end of the teflon sheath was noted at approximately 33.5cm from the iabc distal tip; liquid blood was noted within the sheath sidearm.An ap tubing was connected to the iabc luer; clear fluid was noted within the ap tubing.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 11.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Blood was also 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; no damage or abnormalities were noted.The bladder thickness was measured at six points with measurements ranging from (b)(4).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 successfully aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The cal key and fos were connected to the iabp.The cal key was recognized.The cal key was disconnected and re-connected again after rotating the cal key 180 degrees; the cal key was recognized again.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The fiber was found broken approximately 1.3cm from the iabc distal tip.The full length of the fiber was confirmed present with no other notable breaks.The iabc was leak tested.A leak was immediately detected from the bladder membrane.Under microscopic inspec tion, a puncture consistent with damage from the broken fiber was noted approximately 1.7cm 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 11.3cm 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 65.3cm 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 risk is acceptable.This will be monitored for any developing trends.The risk for the additional finding of blood noted in the helium pathway is acceptable.The reported complaint of iab fos would not zero is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.Additionally, unrelated to the reported complaint, dried blood was noted within the helium pathway upon return.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal end of the bladder membrane which allowed blood to enter 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 broken fiber.The root cause of the broken fiber is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16184075
• MDR Text Key: 308535462
• Report Number: 3010532612-2023-00032
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F22A0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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: NONE REPORTED; NONE REPORTED