MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN038077

Device Problem Difficult to Advance (2920)

Patient Problems Exsanguination (1841); Hematoma (1884)

Event Date 06/15/2023

Event Type  Injury  

Event Description

It was reported that "an attempt was made to advance a guide and place a 40 cc intra-aortic counter pulsation balloon.However, the balloon did not advance beyond the aortoiliac bifurcation despite multiple attempts.Upon balloon removal, it was observed that the guide was adhered to it, which hindered its displacement.For this reason, both the balloon and the guide were removed.During the extraction, a deformity in the introducer was noticed, so it was also removed.Compression with femostop was applied to the right femoral artery, and a compressive dressing was applied using gauze and adhesive tape.The patient was explained the reasons for aborting the procedure, and the cardiovascular surgery team was informed.At that time, the patient had no bleeding or hematoma.However, after 20 minutes, the patient was transferred to the operating room, where peripheral vascular repair was performed due to the presence of an expanding hematoma at the puncture site.Additionally, a retroperitoneal hematoma associated with the event was identified, which required surgical intervention".Additional information states "the patient was not in critical condition, but required preoperative cardiac evaluation due to significant obstructive atherosclerotic disease in 4 vessels with severe involvement of the left main coronary artery.The patient developed a left femoral hematoma and required intraoperative vessel suturing, with suspicion of retroperitoneal hematoma.5 units of packed red blood cells, 6 units of plasma, 6 units of cryoprecipitate, and 2 units of platelets were transfused.The patient was discharged on (b)(6) 2023".

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The reported lot number: (18f22e0039) matches the lot number for the returned sample.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag.Upon return, a 0.025in guidewire was noted inserted within the iabc central lumen.The one-way valve was connected and tethered to the short driveline tubing (inp-5).The bladder was fully unwrapped.A small amount of dried blood was noted on the exterior of the iabc bifurcate; no obvious blood was noted within the helium pathway.Returned with the iabc was a 9.5fr teflon sheath.The sheath tip was noted damaged.The damage is consistent with the sheath tip being partially folded inside the sheath extrusion.The sheath hub appeared typical.No obvious blood was noted on the sheath.The bladder thickness was measured at six points with measurements ranging from 0.0072in-0.0076in and was within specification.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 q-96.The guidewire returned within the iabc central lumen was removed without difficulty.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 using the lt-l-015 in accordance with testing methods from manufacturing procedure 21-7214 rev.15.A leak was immediately detected from the bladder membrane near the distal tip.Under microscopic inspection, a puncture on the iabc bladder, consistent with contact from a sharp object, was noted at approximately 0.6cm from the iabc distal tip.During the inspection of the leak site and bladder, a small amount of blood was noted within the bladder.No other leaks were detected.The returned 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; 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.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.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 for insertion difficulty is confirmed.The returned intra-aortic balloon catheter (iabc) was noted with a puncture to the bladder, consistent with contact from a sharp object.A bladder leak could cause difficulty prepping the device and result in insertion difficulty.Additionally, a sheath was returned with the sample and the sheath tip was noted damaged.It cannot be determined if the damaged sheath caused any insertion difficulty or became damaged as a result of insertion difficulty.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 leak is undetermined.The most probable potential cause of how the catheter came into contact with a sharp object is customer handling.No further action required at this time.This will be monitored for any developing trends.

Event Description

It was reported that "an attempt was made to advance a guide and place a 40 cc intra-aortic counter pulsation balloon.However, the balloon did not advance beyond the aortoiliac bifurcation despite multiple attempts.Upon balloon removal, it was observed that the guide was adhered to it, which hindered its displacement.For this reason, both the balloon and the guide were removed.During the extraction, a deformity in the introducer was noticed, so it was also removed.Compression with femostop was applied to the right femoral artery, and a compressive dressing was applied using gauze and adhesive tape.The patient was explained the reasons for aborting the procedure, and the cardiovascular surgery team was informed.At that time, the patient had no bleeding or hematoma.However, after 20 minutes, the patient was transferred to the operating room, where peripheral vascular repair was performed due to the presence of an expanding hematoma at the puncture site.Additionally, a retroperitoneal hematoma associated with the event was identified, which required surgical intervention".Additional information states "the patient was not in critical condition, but required preoperative cardiac evaluation due to significant obstructive atherosclerotic disease in 4 vessels with severe involvement of the left main coronary artery.The patient developed a left femoral hematoma and required intraoperative vessel suturing, with suspicion of retroperitoneal hematoma.5 units of packed red blood cells, 6 units of plasma, 6 units of cryoprecipitate, and 2 units of platelets were transfused.The patient was discharged on (b)(6) 2023".

• Brand Name: REDIGUARD IAB: 8FR 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: 17325345
• MDR Text Key: 319270145
• Report Number: 3010532612-2023-00386
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902136732
• UDI-Public: 00801902136732
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN038077
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22J0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• 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
• Treatment: N/A.; N/A.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 72 KG