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

Model Number	IPN038075
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that an iab was inserted in the right femoral in the cath lab.The placement was verified via fluoroscopy, was sutured in place, and a statlock added for further securement.The next day in the ccu, the iab was noted to still be securely sutured in at the appropriate points and statlock remained in place.It was noted that the distal end of the cath-guard contamination shield had come unsealed due to an unknown cause".As a result, the catheter was removed and a 2nd iab was inserted at a different insertion site, in the left femoral.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that an iab was inserted in the right femoral in the cath lab.The placement was verified via fluoroscopy, was sutured in place, and a statlock added for further securement.The next day in the ccu, the iab was noted to still be securely sutured in at the appropriate points and statlock remained in place.It was noted that the distal end of the cath-guard contamination shield had come unsealed due to an unknown cause".As a result, the catheter was removed and a 2nd iab was inserted at a different insertion site, in the left femoral.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The serial number on the returned sample is (b)(6).The lot number (18f22m001) reported on the complaint report is an incomplete lot number.The lot number of the returned sample is 18f23a0037.The documents returned with the sample indicated this was the correct sample for the complaint.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a padded shipping envelope and was in a bio-hazard bag.Upon return, a portion of the bladder was noted covered by the teflon sheath.The distal end of the teflon sheath was noted at approximately 15.1cm from the iabc distal tip; liquid blood/clear fluid was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The exposed portion of the bladder was fully unwrapped.A red pressure connector was noted connected to the iabc luer.Bends to the iabc were noted at approximately 5.3cm , 38.2cm, 42.8cm, 60cm and 73.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc.A dried green media was noted on the exterior surfaces of the iabc.No blood was noted within the helium pathway.Upon return, the hemostasis/stat-loc cuff was noted disconnected from the iabc bifurcate and a section of the outer lumen was exposed.No obvious damage or abnormalities were noted to the cuff and bifurcate.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 hemostasis cuff was reconnected to the iabc bifurcate, no issues or abnormalities were noted with the connection.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Some blood was noted.Upon receipt, the teflon sheath was noted on a section of the bladder membrane, however there is no evidence that the user attempted to remove the iabc and bladder through the sheath.The one-way valve was connected to the short driveline tubing and vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was moved from the bladder and towards the bifurcate without difficulty.The bladder appeared typical; no damage or abnormalities were noted to the bladder.The iabc was leak tested using the lt-l-015 in accordance with testing methods from manufacturing procedure 21-7214 rev.15.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.4cm, 60.1cm and 73.1cm from the iabc distal tip, which are the locations of the previously noted bends.The guidewire was able to advance through the central lumen.Some blood was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 9.1cm from the iabc luer, which is the location of a previously noted bend.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 of iab connection problem is confirmed.The hemostasis/stat-loc cuff was noted disconnected from the iabc bifurcate.During the investigation, the connection between the hemostasis/stat- loc cuff and the iabc bifurcate was tested, and no issues or abnormalities were 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 disconnected hemostasis cuff.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16799544
• Report Number: 3010532612-2023-00222
• Device Sequence Number: 14262289
• Product Code: DSP
• UDI-Device Identifier: 00801902136695
• UDI-Public: 00801902136695
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/18/2023

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: IPN038075
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23A0037
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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: Male