MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05830-U
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	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported by the rn that there is a bloody, frothy looking condensate in the helium drive line tubing, the nurse stated that he has not had any alarms.The clinical support specialist explained to the rn that the intra-aortic balloon (iab) had to be removed as soon as possible.The rn reported that the message would be related to the md.There was no report of patient injury or consequence.
Additional Manufacturer Narrative
Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed based on visual inspection of the device.The cause of the complaint was unable to be determined due to the returned state of the device.The iab was returned with a broken central lumen and damaged outer lumen.Additionally, the iab bladder had a full thickness abrasion.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.It cannot be confidently determined which damage occurred first.The root cause of how the blood entered the helium pathway is undetermined.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 revised risks.This will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported by the rn that there is a bloody, frothy looking condensate in the helium drive line tubing, the nurse stated that he has not had any alarms.The clinical support specialist explained to the rn that the intra-aortic balloon (iab) had to be removed as soon as possible.The rn reported that the message would be related to the md.There was no report of patient injury or consequence.

• Brand Name: ULTRA 8 IAB: 8FR 30CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9410840
• Report Number: 3010532612-2019-00423
• Device Sequence Number: 19291446
• Product Code: DSP
• UDI-Device Identifier: 00801902010742
• UDI-Public: 00801902010742
• 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): 11/11/2019

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: 12/31/2020
• Device Catalogue Number: IAB-05830-U
• Device Lot Number: 18F19A0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACORPOREAL MEMBRANE OXYGENATION.; EXTRACORPOREAL MEMBRANE OXYGENATION.; EXTRACORPOREAL MEMBRANE OXYGENATION.