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

Model Number IPN917530

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported that "a few minutes after insertion, the presence of blood in the helium connection tube was highlighted".As a result, the iab was removed.No patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4) other remarks: n/a corrected data: n/a.

Event Description

It was reported that "a few minutes after insertion, the presence of blood in the helium connection tube was highlighted".As a result, the iab was removed.No patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The reported complaint that the "presence of blood in the helium connection tube" was confirmed upon investigation of the returned s ample.The customer returned a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in a cardboard box and was in a sealed bio-hazard bag (inp-1, inp-2).Upon return, the iabc central l umen within the flex-tip assembly area was immediately noted damaged; the wire round/polyimide (part of the flex tip assembly) was noted no longer attached and separated from the inner cannula (iabc central lumen) at approximately 6.7cm from the iabc distal tip (inp-9, inp-10).The one-way valve was tethered to the short driveline tubing (inp-5).A non-teleflex 20ml syringe was noted connected to the iabc luer (inp-5).The supplied inflation driveline tubing was noted connected to iabc short driveline tubing; the inflation driveline tubing was noted cut and the remaining length including the connector was not returned with the sample (inp-5, inp-6).The bladder was fully unwrapped (inp-7).A bend to the iabc central/outer lumen was noted at approximately 47.5cm from the iabc distal tip (inp-8).Dried blood was noted on the exterior surfaces of the returned sample.Spots of dried blood were also noted within the iabc helium pathway.No other visual damage or abnormalities were noted to the returned sample.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 in accordance with quality system document.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation.The results are consistent with the previously noted damaged central lumen (inp-9, inp-10).The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end (anp-1, anp-2).The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed damaged/separated central lumen (inp-9, inp-10).The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire exited the central lumen and entered the bladder at the location of the damaged/separated flex-tip assembly.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 33cm from the iabc luer, which is the location of the previously noted bend.Then the guidewire then exited the central lumen and entered the bladder at the location of the inner cannula separation.No blood or debris was noted.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 damaged central lumen.The root cause of the complaint was undetermined.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18073478
• MDR Text Key: 327403270
• Report Number: 3010532612-2023-00600
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN917530
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23H0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2023
• 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