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

Model Number	IPN915322
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood was noted in the driveline tubing, the iab had ruptured.As a result, the iab was removed.At the time of this report, the patient is on the or schedule for replacement of iab.No patient harm or injury.Patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn # (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that blood was noted in the driveline tubing, the iab had ruptured.As a result, the iab was removed.At the time of this report, the patient is on the or schedule for replacement of iab.No patient harm or injury.Patient status is reported as "fine".
Event or Problem Description
It was reported that blood was noted in the driveline tubing, the iab had ruptured.As a result, the iab was removed.At the time of this report, the patient is on the or schedule for replacement of iab.No patient harm or injury.Patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint for "blood in the driveline" was confirmed upon investigation of the returned sample.The customer returned a 40cc 7.5fr ultra intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag (inp-1, inp-2).Returned with the sample was a portion of the teflon sheath including sheath hub; the sheath extrusion was noted cut and was not returned (inp-4, inp-8).Upon return, the datascope driveline tubing was noted connected to the short driveline tubing; blood was noted in the tubing (inp-4, inp-5).The one-way valve and the one-way valve tether were not returned with the sample.A three-way stop valve was noted connected to the iabc luer (inp-6).The iabc bladder was fully unwrapped (inp-7).Bends to the iabc central lumen were noted at approximately 5.1cm, 41.1cm and 67.2cm from the iabc distal tip (inp-9, inp-10, inp-11).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.As part of functional inspection, an attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked central lumen.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire could not be front loaded through the iabc luer.Upon further investigation, the iabc central lumen was noted broken at approximately 74.1cm from the iabc distal tip (anp-1).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 is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16827825
• Report Number: 3010532612-2023-00223
• Device Sequence Number: 15084670
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: 10801902161946
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2023

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: 12/31/2024
• Device Model Number: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23A0054
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 03/15/2024
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/01/2023; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: 27 YR
• Patient Sex: Male
• Patient Weight: 91 KG