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

Model Number	IPN039778
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states that "the machine alarmed and found that blood appeared in the helium tube, and [the physician] withdrew the catheter.[the physician] rinsed the removed catheter, and after flushing, it was found that the central cavity was ruptured.As a result, a second iab was inserted at a different insertion site".Patient status was "critical" prior to event.
Additional Manufacturer Narrative
(b)(4).The lot number (18f22g0001) reported on the complaint report matches the lot number for the returned sample.No serial number was reported.The serial number of the returned sample is (b)(6).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc).The sample was returned in a brown cardboard box and was in a biohazard bag within an original packaging box.The lot and serial number on the returned original packaging box was unable to be read.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc central lumen was noted broken within the flex-tip assembly area at approximately 5.3cm from the iabc distal tip.A kink to the iabc central lumen was noted at approximately 7.8cm from the iabc distal tip.No blood was noted on the interior or the exterior surfaces of the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0061in-0.0067in.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.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 occurrence rate is within acceptable risk limits.A non-conformance has been initiated to further investigate the issue.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc distal tip, which caused blood to enter the helium pathway.The returned iabc bladder membrane was fully intact, with no leaks 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 broken central lumen.The root cause of the broken central lumen is undetermined.This will be monitored for any developing trends.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
The report states that "the machine alarmed and found that blood appeared in the helium tube, and [the physician] withdrew the catheter.[the physician] rinsed the removed catheter, and after flushing, it was found that the central cavity was ruptured.As a result, a second iab was inserted at a different insertion site".Patient status was "critical" prior to event.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15721955
• Report Number: 3010532612-2022-00466
• Device Sequence Number: 15339189
• Product Code: DSP
• UDI-Device Identifier: 10801902145618
• UDI-Public: 10801902145618
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 06/30/2024
• Device Model Number: IPN039778
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22G0001
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 58 KG