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

Catalog Number IAB-05840-LWS

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

Patient Problems Congestive Heart Failure (1783); Low Cardiac Output (2501)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).See also mdr #1219856-2017-00058.

Event Description

It was reported that the event involved a patient of (b)(6) in height.The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the cath lab.On (b)(6) 2017, the iab was repositioned by cardiology.The patient was sitting up later that evening when the balloon ruptured.Cardiology at bedside for iab removal/cut-down reversal.Patient was taken to the operating room (or) the following day for va-ecmo (ventricular assist-extracorporeal membrane oxygenation).Length of time in use prior to event was less than 13 days.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of blood in helium pathway is confirmed.The iab was found kinked and the central lumen was found to be broken.The broken central lumen allowed blood to enter the helium pathway.The root cause of the kink is undetermined.A device history record (dhr) review was conducted with no relevant findings.Teleflex assessed the risk for the reported complaint and there are no new or revised risks.We will continue to monitor for trends.Other remarks: please refer to mdr #1219856-2017-00058/(b)(4) related to this complaint.

Event Description

It was reported that the event involved a patient of (b)(6) in height.The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the cath lab.On (b)(6) 2017, the iab was repositioned by cardiology.The patient was sitting up later that evening when the balloon ruptured.Cardiology at bedside for iab removal/cut-down reversal.Patient was taken to the operating room (or) the following day for va-ecmo (ventricular assist-extracorporeal membrane oxygenation).Length of time in use prior to event was less than 13 days.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• 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: 6437442
• MDR Text Key: 70969985
• Report Number: 1219856-2017-00059
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16G0030
• Other Device ID Number: 00801802007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 88