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

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem Chest Pain (1776)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted and the patient was transferred from one hospital to another and upon arrival, large amount of blood was noted in tubing.Unknown if alarms occurred.The operation was ceased and tubing was clamped.Patient began to experience pain in left arm.The balloon was removed and the patient was given nitroglycerine.No new balloon inserted.Patient underwent cardiac surgery for underlying disease and is stable.Patient outcome reported as stable.There is no report of patient death or serious injury.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted and the patient was transferred from one hospital to another and upon arrival, large amount of blood was noted in tubing.Unknown if alarms occurred.The operation was ceased and tubing was clamped.Patient began to experience pain in left arm.The balloon was removed and the patient was given nitroglycerine.No new balloon inserted.Patient underwent cardiac surgery for underlying disease and is stable.Patient outcome reported as stable.There is no report of patient death or serious injury.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab which allowed blood to enter the helium pathway.The root cause of the broken fiber 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.A nonconformance has been initiated to further investigate the root cause.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7491493
• MDR Text Key: 107565315
• Report Number: 3010532612-2018-00125
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17K0005
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NITROGLYCERINE; NITROGLYCERINE