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

Catalog Number IAB-06840-U

Device Problems Device Alarm System (1012); Material Puncture/Hole (1504)

Patient Problems Atrial Fibrillation (1729); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 08/19/2017

Event Type  Death  

Manufacturer Narrative

Medical devices: scitation, inotropes administered, patient cardioverted x3 unresponsive to treatment.Dialysis ceased.Qn#(b)(4).

Event Description

It was reported that the event occurred during use in the intensive care unit.The intra-aortic balloon (iab) was inserted in the patient and the balloon rapidly filled with blood.As a result, the intra-aortic balloon pump (iabp) was stopped and the balloon catheter was removed.The iab was not replaced.Iabp alarm: high pressure.Further information received: the patient remained in atrial fibrillation and the patient's blood pressure started to trend down.The patient was medically treated.Additional information received: the patient was not affected by removal of the iab.The patient deceased at a time thereafter.

Manufacturer Narrative

Concomitant medical products: scitation.Inotropes administered.Patient cardioverted x3 unresponsive to treatment.Dialysis ceased (b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.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.We will continue to monitor for any developing trends.No further action is required at this time.

Event Description

It was reported that the event occurred during use in the intensive care unit.The intra-aortic balloon (iab) was inserted in the patient and the balloon rapidly filled with blood.As a result, the intra-aortic balloon pump (iabp) was stopped and the balloon catheter was removed.The iab was not replaced.Iabp alarm: high pressure.Further information received: the patient remained in atrial fibrillation and the patient's blood pressure started to trend down.The patient was medically treated.Additional information received: the patient was not affected by removal of the iab.The patient deceased at a time thereafter.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6897405
• MDR Text Key: 87493874
• Report Number: 1219856-2017-00211
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F16F0016
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMIODARONE 150 MGARAMINEADRENALINEFLUID RESU
• Patient Outcome(s): Death