MAUDE Adverse Event Report: ARROW INTL., INC. IAB : 7.5 FR - 40 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-06840-U

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)

Patient Problem Myocardial Infarction (1969)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

It was reported that the rn from the intensive care unit called due to loss of ap (arterial pressure) waveform on the intra-aortic balloon pump (serial number (b)(4)).The rn stated the 40cc fluid filled intra-aortic balloon (iab) was inserted less than 12 hours ago for a patient with stemi (segment elevation myocardial infarction).Just recently, the ap waveform flattened and "no ap waveform available" message appeared on the pump.The pump was in autopilot utilizing pattern trigger.Heparinized nss (normal saline solution) flush was connected to the central lumen.The sheath sideport was connected to the bedside monitor with a "dampened" ap tracing.The clinical support specialist (css) verified that there was no disruption in pump and the iabp continued to pump using the ecg tracing.The rn was unable to fast flush or aspirate the central lumen.The css explained this would indicate that the central lumen is no longer patent and an alternative ap source needed to be brought to the pump.The rn was able to transduce the sideport directly to the pump console and ap waveform was now present on iabp.The css explained why the sideport had a dampened waveform and another ap source may ned to be obtained (radial arterial line) if the sideport is not consistent or too dampened.The css requested that the rn mark the central lumen as clotted and to save the iab after removal for return.Pump strips were not generated, x-rays were not performed and as a result, strips and x-rays are not available for review.The outcome of the patient is noted as the patent is still on pump.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB : 7.5 FR - 40 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc. ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4128793
• MDR Text Key: 4924071
• Report Number: 1219856-2014-00178
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: No
• 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