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

Model Number	IPN039791
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "after insertion, the iab was connected to the pump and the pump gave a 'helium loss' alarm.[the clinician] tried a second pump, but the same alarm was reported".Additional information states "the iab was removed and no second attempt [to insert a secondary catheter] was performed".The patient was "treated with different therapy, other than iab".The customer stated that the "patient was critically ill before the incident" and that the current condition of the patient is "unknown".Further information states that there were no issues with either pump.
Additional 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 (18f21f0029) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 30cc 8.0fr fiberoptix ultra (fos) intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed bio-hazard bag.Upon return, the distal end of the teflon sheath was noted at approximately 37.2cm from the iabc distal tip; clear fluid was noted within the sheath sidearm.The one-way valve was connected and tethered to the short driveline tubing.A non-teleflex short arterial pressure tubing was connected to the iabc luer end; clear fluid was noted within the ap tubing.The bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the iabc 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 fos yellow jacket was pulled away from the gray connector.The cal key was intact.The bladder thickness was measured at six points with measurements ranging from 0.0057in-0.0066in.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.The cal key was recognized.The fos was connected and the iabp zeroed the iabc.The pump status displayed "ok" indicating the fiber is fully intact.The iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.Dried blood was noted.The iabc was leak tested.A leak was immediately detected from the bifurcate around the fos adhesive.Upon microscopic inspection, an external leak occurred from the fos adhesive bond at the bifurcate and the appearance of the adhesive is consistent with showing a void.No other leaks were detected.A 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.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.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.A non-conformance was opened/closed to further investigate this issue.As a result, corrections have been completed.The reported complaint of iab helium loss alarm is confirmed.During the investigation, an external leak was confirmed from the iabc bifurcate fos adhesive.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 leak at the bifurcate fos adhesive.The root cause of the leak at the bifurcate fos adhesive is manufacturing related.No further action required at this time.This will be monitored for any developing trends.Corrections have been established for this issue as a result of a previous non-conformance, and this device was manufactured prior to the release of those corrections.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "after insertion, the iab was connected to the pump and the pump gave a 'helium loss' alarm.[the clinician] tried a second pump, but the same alarm was reported".Additional information states "the iab was removed and no second attempt [to insert a secondary catheter] was performed".The patient was "treated with different therapy, other than iab".The customer stated that the "patient was critically ill before the incident" and that the current condition of the patient is "unknown".Further information states that there were no issues with either pump.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Common Device Name: 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: 15654699
• Report Number: 3010532612-2022-00454
• Device Sequence Number: 2455425
• Product Code: DSP
• UDI-Device Identifier: 10801902145694
• UDI-Public: 10801902145694
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: IPN039791
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21F0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 75 KG