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

Catalog Number IAB-06840-U

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528)

Patient Problem Cardiac Arrest (1762)

Event Date 08/05/2023

Event Type  Death  

Event Description

It was reported that "the patient was admitted to ccu due to heart attack and heart failure on (b)(6) 2023, and underwent catheterization pci on (b)(6) 2023, and his blood pressure was reduced to 60/40 mmhg, and then the left femoral artery was punctured successfully, and the left femoral artery was implanted with an iabp to perform balloon counterpulsation.2:15 a.M.On (b)(6) 2023, the nurse found a small amount of blood oozing from the connecting tube, and immediately notified the doctor, who actively contacted the physician to confirm that there was no displacement of the balloon position.Contacted radiographs to confirm that there was no displacement of the balloon position.The equipment department was notified to check the balloon counterpulsation pump, and the equipment department confirmed that the instrument was normal.Because the catheter was out of stock and could not be repositioned, close observation was conducted for the time being.Between (b)(6), the catheter was closely observed for blood seepage with no significant change.At 15:28 on (b)(6), a large amount of blood appeared in the catheter inflatable tube, and the aortic pump was automatically shut down, so the balloon rupture was considered, and the catheter was prepared to be withdrawn.Sheath and catheter were found to be difficult to withdraw, consider balloon jamming, immediately contact surgery for emergency consultation, consider balloon jamming, consider surgical withdrawal, incise the skin in the left inguinal region and try to withdraw the balloon.Unsuccessful.The catheter inside the balloon was broken, only the plastic balloon was connected, and it was difficult to remove the balloon with high resistance after it lost support.The patient had a sudden ventricular fibrillation during the operation, and was immediately resuscitated, and the patient died after unsuccessful resuscitation." additional information states that the cause of death is myocardial infarction and heart failure.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f23e0014) reported on the complaint report does not match the lot number for the returned sample.The lot number for the returned sample is 18f23f0014.Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Returned with the sample was supplied 40cc inflation driveline tubing; dried/liquid blood was noted within the returned inflation driveline tubing.Upon return, the iabc was received without the following: the iabc distal tip, the entire bladder, and a section of both the central/outer lumen.The total length of the returned iabc section, from the luer on the bifurcate to the cut down, is approximately 38cm.The appearance at the area of the broken outer lumen and central lumen was consistent with being cut from a sharp.The teflon sheath hub was noted at approximately 17.3cm from the iabc luer end; dried/liquid blood was noted within the teflon sheath sidearm.The one-way valve was tethered to the short driveline tubing.A wooden stick was noted inserted within the iabc short driveline tubing; liquid blood was noted within the short driveline tubing.The wooden stick was removed from the short driveline tubing without any difficulty.Upon removal, the wooden stick is appeared to be a cotton swab stick.A bend to the iabc central/outer lumen was noted at approximately 10.8cm from the iabc luer end.Dried blood was noted on the exterior surfaces of the returned sample.Photos provided by the customer were reviewed.The first photo showed a portion of the damaged iabc and blood was confirmed present within the iabc short driveline tubing.The second photo showed the supplied 40cc inflation driveline tubing and blood was confirmed present within the inflation driveline tubing.The findings in the pictures are consistent with the reported event.Additionally, according to the event details, "2:15 a.M.On (b)(6) 2023, the nurse found a small amount of blood oozing from the connecting tube.Between august 2 and 4, the catheter was closely observed for blood seepage with no significant change.At 15:28 on august 5 , a large amount of blood appeared in the catheter inflatable tube, and the aortic pump was automatically shut down, so the balloon rupture was considered, and the catheter was prepared to be withdrawn." this indicates the user did not follow the instructions for use (ifu).The instructions for use (ifu) states: warnings: if you suspect balloon perforation: o immediately stop pumping.Consider tapering or discontinuing anticoagulation therapy.O remove iab from patient, using recommended removal technique.Additionally, in the iabp operation manual states: "if blood is present, do not resume pumping.Contact the physician and prepare for iab removal.If the patient still requires iabp support, prepare a new iab for insertion." the one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated five separate times according to quality system document q-96 with similar results.Blood was noted within the interior surfaces of the one-way valve upon cleaning.The one-way valve was properly cleaned and tested again; the one-way valve 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 according to quality system document q-96.An attempt to aspirate and flush the iabc central lumen 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.A lab inventory 0.025in guidewire was front loaded through the iabc luer end.Resistance was noted at approximately 10.9cm from the iabc luer, which is the location of the previously noted bend.Then the guidewire could not advance at approximately 20.5cm from the iabc luer due to the blocked central lumen.Further functional testing could not be performed due to the returned state of the device.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 that "a large amount of blood appeared in the catheter inflatable tube" is confirmed based on the visual inspection.During the investigation of the returned device, blood was confirmed within the helium pathway.The cause of how the blood entered the helium pathway was unable to be determined due to the returned state of the device.The returned iabc was too damaged to analyze.Additionally, based on the event details, "2:15 a.M.On august 1, 2023, the nurse found a small amount of blood oozing from the connecting tube.Between august 2 and 4, the catheter was closely observed for blood seepage with no significant change.At 15:28 on august 5, a large amount of blood appeared in the catheter inflatable tube , and the aortic pump was automatically shut down, so the balloon rupture was considered, and the catheter was prepared to be withdrawn." this indicates the user did not follow the instructions for use (ifu).As a result, a customer in-service has been requested to review the instructions for use (ifu) with the customer.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 blood in the helium pathway.The root cause of the complaint is undetermined.This will be monitored for any developing trends.Other remarks: n/a corrected data: n/a.

Event Description

It was reported that "the patient was admitted to ccu due to heart attack and heart failure on (b)(6) 2023, and underwent catheterization pci on (b)(6) 2023, and his blood pressure was reduced to 60/40 mmhg, and then the left femoral artery was punctured successfully, and the left femoral artery was implanted with an iabp to perform balloon counterpulsation.2:15 a.M.On (b)(6) 2023, the nurse found a small amount of blood oozing from the connecting tube, and immediately notified the doctor, who actively contacted the physician to confirm that there was no displacement of the balloon position.Contacted radiographs to confirm that there was no displacement of the balloon position.The equipment department was notified to check the balloon counterpulsation pump, and the equipment department confirmed that the instrument was normal.Because the catheter was out of stock and could not be repositioned, close observation was conducted for the time being.Between august 2 and 4, the catheter was closely observed for blood seepage with no significant change.At 15:28 on august 5, a large amount of blood appeared in the catheter inflatable tube, and the aortic pump was automatically shut down, so the balloon rupture was considered, and the catheter was prepared to be withdrawn.Sheath and catheter were found to be difficult to withdraw, consider balloon jamming, immediately contact surgery for emergency consultation, consider balloon jamming, consider surgical withdrawal, incise the skin in the left inguinal region and try to withdraw the balloon.Unsuccessful.The catheter inside the balloon was broken, only the plastic balloon was connected, and it was difficult to remove the balloon with high resistance after it lost support.The patient had a sudden ventricular fibrillation during the operation, and was immediately resuscitated, and the patient died after unsuccessful resuscitation." additional information states that the cause of death is myocardial infarction and heart failure.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17586508
• MDR Text Key: 321565175
• Report Number: 3010532612-2023-00474
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23F0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 70 KG