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

Catalog Number IAB-05840-LWS

Device Problems Occlusion Within Device (1423); Positioning Problem (3009)

Patient Problem Loss Of Pulse (2562)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported from a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) is calling with concerns about the balloon pressure waveform (bpw).The patient was in an assist ratio of 1:2, heartrate (hr) is 90 ans nsr (normal sinus rhythm).Pump is in autopilot and fiber optic sensor (fos) light bulb is green (fiber optic intra-aortic balloon (iab) zeroed prior to insertion).The rn is concerned that the patient's u/o (urine output) is decreased and the patient lost dorsalis pedal pulses bilaterally but still has bilateral post tibia pulses.The clinical support specialist explained to the rn that the balloon pressure waveform (bpw) is due to the patient's heart rate, the rn verbalized understanding.The unit educator called a second clinical support specialist directly after speaking with the rn.The unit educator was concerned that the pressure bag was only saline and not heparinized saline.The central lumen had clotted off.The clinical support specialist (css) discussed potential complications with a clotted central lumen, and the clinical support specialist (css) told the unit educator to make sure no one tried to flush or use a guidewire.As long as the fiber optic sensor (fos) was working, there is not a need to place another arterial line (a-line).The css and unit educator also discussed malposition of the intra-aortic balloon (iab) and the potential for decreased urine output (u/o) and peripheral pulses.Per the unit educator, they were going to ask for a chest x-ray to verify placement.

Manufacturer Narrative

(b)(4).Evaluation: the reported complaint that the central lumen was occluded is unable to be confirmed since the product was not returned for evaluation.The specific lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers shipped to this account with no relevant findings.Teleflex will continue to monitor for trending data.

Event Description

It has been reported from a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) is calling with concerns about the balloon pressure waveform (bpw).The patient was in an assist ratio of 1:2, heartrate (hr) is 90 ans nsr (normal sinus rhythm).Pump is in autopilot and fiber optic sensor (fos) light bulb is green (fiber optic intra-aortic balloon (iab) zeroed prior to insertion).The rn is concerned that the patient's u/o (urine output) is decreased and the patient lost dorsalis pedal pulses bilaterally but still has bilateral post tibia pulses.The clinical support specialist explained to the rn that the balloon pressure waveform (bpw) is due to the patient's heart rate, the rn verbalized understanding.The unit educator called a second clinical support specialist directly after speaking with the rn.The unit educator was concerned that the pressure bag was only saline and not heparinized saline.The central lumen had clotted off.The clinical support specialist (css) discussed potential complications with a clotted central lumen, and the clinical support specialist (css) told the unit educator to make sure no one tried to flush or use a guidewire.As long as the fiber optic sensor (fos) was working, there is not a need to place another arterial line (a-line).The css and unit educator also discussed malposition of the intra-aortic balloon (iab) and the potential for decreased urine output (u/o) and peripheral pulses.Per the unit educator, they were going to ask for a chest x-ray to verify placement.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: FIBER-OPTIC INTRA AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 6145720
• MDR Text Key: 61464453
• Report Number: 1219856-2016-00278
• 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: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: N/A
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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