MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ML 2012, AFIB, HT N, CAD, HLD, HFREF 15%, ISCH; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN039788
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "ruptured iab".It was reported that approximately 48 hours after insertion of the iab at the left axillary site, blood was noted in the driveline.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of iab blood in helium pathway was confirmed based upon the sample received.The customer returned a 40cc 7.5fr ultraflex 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).Upon return, a clear plastic tubing was noted tethered around the iabc cathguard (inp-4, inp-5).The one-way valve was connected and tethered to the short driveline tubing (inp-6).The bladder was fully unwrapped (inp-7).Two bends to the iabc were noted at approximately 38.5cm and 73cm from the iabc distal tip (inp-8, inp-9).Dried blood was noted on the exterior surfaces of the returned iabc.Dried/liquid blood was noted within the iabc helium pathway.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 with similar results.Blood was noted within the one-way valve and one-way valve seal 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.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 the iabc bladder inflation indicating crossover leak between the iabc central lumen and helium pathway.The clear plastic tubing was removed from the iabc cathguard (anp-1).Upon removal of the clear tubing, the iabc central lumen was noted damaged/broken, at the previously noted bent central lumen, at approximately 73cm from the iabc distal tip (inp-9, anp-2).The iabc was leak tested using the lt-l-015 in accordance with testing methods from manufacturing procedure 21-7214 rev.15.A leak was immediately detected from the iabc distal tip and iabc luer end (anp-3, anp-4).The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen (anp-2).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.Resistance was noted at approximately 38.5cm from the iabc distal tip, which is the location of the previously noted bend.The guidewire could not advance at approximately 72.8cm from the iabc distal tip, which is the location of the previously noted damaged/broken central lumen.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 9.2cm from the iabc luer, which is the location of the previously noted damaged/broken central lumen.Some blood was noted on the guidewire.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.However, the specifications were not met during the complaint investigation due to the broken central lumen.The root cause of the broken central lumen was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Additional information received on 26 june 2023 states that "the initial procedure was a single successful attempt.Heparin drip was held prior to iab placement, patient received 5000 iu of heparin intra-op, and heparin drip was resumed the next day.There was a kink near the helium tubing junction with the iabp line.[the first attempt] was successful, however, poor flow back with thrombus formation was noted.Thrombus was milked out and thrombectomy was performed before a new iab was placed.Patient is doing well post-op".Further information received on 06 july 2023 states that the thrombus was discovered during the removal of the iab.Per the customer, it is not known if the thrombus was located in the catheter or the patient's vasculature.The customer did not provide requested details surrounding the "milking out" of the thrombus only that "a thrombectomy was performed to remove the thrombus and improve blood flow".If further information is received, the complaint file will be updated.
Event or Problem Description
Reported as "ruptured iab".It was reported that approximately 48 hours after insertion of the iab at the left axillary site, blood was noted in the driveline.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ML 2012, AFIB, HT N, CAD, HLD, HFREF 15%, ISCH
• 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 27560
• MDR Report Key: 17198430
• Report Number: 3010252479-2023-00167
• Device Sequence Number: 12436160
• Product Code: DSP
• UDI-Device Identifier: 10801902145731
• UDI-Public: 10801902145731
• 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
• Report Date (Section B): 05/31/2023

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: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23A0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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 Sex: Female
• Patient Weight: 73 KG