MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000255
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that when the patient arrived from the or and the staff experienced helium loss 2 alarms.The staff noted blood in the tubing and the intra-aortic balloon (iab) was removed.There was no difficulty in removing the iab and the patient was stabled after removal and discharged from the hospital.There was no report of patient complications, serious injury or death.
Event or Problem Description
It was reported that when the patient arrived from the or and the staff experienced helium loss 2 alarms.The staff noted blood in the tubing and the intra-aortic balloon (iab) was removed.There was no difficulty in removing the iab and the patient was stabled after removal and discharged from the hospital.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found on the bladder membrane which allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the bladder leak is undetermined.A potential cause is customer handling.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: ULTRA 8 IAB: 8FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10631181
• Report Number: 3010532612-2020-00281
• Device Sequence Number: 3003914
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 01/31/2022
• Device Model Number: IPN000255
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20B0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1