MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IAB: 7.5 FR - 30 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-06830-U

Device Problem Occlusion Within Device (1423)

Patient Problem Myocardial Infarction (1969)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was reported that the rn in the intensive care unit was calling because the arterial pressure (ap) tracing on the intra-aortic balloon pump (iabp) was totally flat.The intra-aortic balloon (iab) was inserted via a sheath in the patient's femoral artery.The rn said that the erg and balloon pressure waveform both have very good waveforms.They tried to reposition the patient, put traction on the iab and they have tried flushing as well; all of this with no change to the ap.The length of time in use prior to the event is 20 hours.The clinical support specialist (css) first verified that the pump (s/n (b)(4)) was currently pumping in autopilot.Timing is (b)(4).The css then had the rn attempt to draw blood from the central lumen.The rn stated that she was unable to draw blood or any fluid.The css explained to the rn that the central lumen was most likely clotted and recommended that they place a radial arterial line to connect to the iabp.The css also recommended that they cap the central lumen and mark it so it is not used.At 1900 the css called back to check in with the rn.According to the rn they have placed a radial a-line and the pump is performing well providing good support.The rn thanked the css for the follow-up.

Manufacturer Narrative

(b)(4).Sample will not be returned for evaluation.

• Brand Name: IAB: 7.5 FR - 30 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory associa ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4290982
• MDR Text Key: 5086109
• Report Number: 1219856-2014-00218
• 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: 11/19/2014

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-06830-U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1