MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06830-U
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "after placement of the catheter, there was no problem at first.However, the balloon got ruptured and blood was noted in helium driveline.Therefore, the catheter was removed and replaced with a new one.No injury to the patient was reported and no medical intervention was required.According to the user, the rupture might have been caused by calcification of the patient's aorta." additional information states that "the initial catheter was inserted from the groin, and the second catheter was inserted from the contralateral groin".Furthermore, "blood was noted in the helium driveline of the 2nd catheter.As a result, the 2nd catheter was removed and replaced with 3rd one.But blood was noted in helium driveline of 3rd catheter.The 3rd catheter was removed.A new catheter wasn't replaced.The patient was under follow-up in the ccu.The balloons got ruptured in all three catheters." no patient harm or injury.The patient status is reported as "fine".See associated mdrs 3010532612-2023-00443 and 3010532612-2023-00444.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after placement of the catheter, there was no problem at first.However, the balloon got ruptured and blood was noted in helium driveline.Therefore, the catheter was removed and replaced with a new one.No injury to the patient was reported and no medical intervention was required.According to the user, the rupture might have been caused by calcification of the patient's aorta." additional information states that "the initial catheter was inserted from the groin, and the second catheter was inserted from the contralateral groin".Furthermore, "blood was noted in the helium driveline of the 2nd catheter.As a result, the 2nd catheter was removed and replaced with 3rd one.But blood was noted in helium driveline of 3rd catheter.The 3rd catheter was removed.A new catheter wasn't replaced.The patient was under follow-up in the ccu.The balloons got ruptured in all three catheters." no patient harm or injury.The patient status is reported as "fine".See associated mdrs#: 3010532612-2023-00443 and #: 3010532612-2023-00444.
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "balloon got ruptured and blood was noted in helium driveline" was confirmed based on the sample received.The customer returned a 30cc 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 clear ziploc bag with protective shipping material (inp-1, inp-2).Upon return, the one-way valve was tethered to the short driveline tubing (inp-5).The supplied 30cc inflation driveline tubing was connected to the iabc short driveline tubing; dried blood spots were noted within the inflation driveline tubing (inp-4).The ap extension tubing assembly was noted connected to the iabc luer; clear fluid noted within the ap tubing (inp-4).The sheath was noted on the iabc with the sidearm cut and dried blood was in the remaining portion of the sidearm (inp-4, inp-6).The bladder was fully unwrapped (inp-7).A bend was noted to the central lumen at approximately 1.7 cm from the iabc distal tip (inp-8).Dried blood was noted on the exterior surfaces of the returned iabc.Dried blood was noted within the iabc helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0056in-0.0065in and was within specification of process document.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.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the bladder membrane (anp-1).Under microscopic inspection, a full thickness abrasion to the bladder was confirmed at approximately 20.8cm from the iabc distal tip and the appearance is consistent with repeated contact with calcified plaque on the aortic wall (anp-2, anp-3).Abrasions were noted throughout the bladder (anp-4).No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 1.7cm from the iabc distal tip, which is the location of the previously noted bend.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.Resistance was noted at approximately 75.3cm from the iabc luer, which is the location of the previously noted bend.The guidewire was able to advance through the central lumen.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 bladder leak.The root cause of the bladder lea k was related to patient condition.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 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17482214
• Report Number: 3010532612-2023-00409
• Device Sequence Number: 17901747
• Product Code: DSP
• UDI-Device Identifier: 00801902136701
• UDI-Public: 00801902136701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000729
• 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): 07/20/2023

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: 01/31/2025
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23B0032
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown