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

Catalog Number IAB-06840-U

Device Problems Entrapment of Device (1212); Fluid/Blood Leak (1250); Difficult to Remove (1528)

Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 04/27/2014

Event Type  Injury  

Event Description

It was reported via a call from the cath lab rn to the clinical support specialist (css) on (b)(6) 2014 at 10:02 (b)(6) that they were having difficulty removing an intra-aortic balloon (iab) from a patient.When the css spoke with the rn, the rn stated that the physician was trying to remove a fluid filled iab from the patient and they could not get the iab out.The iab and sheath were part way out, but they could not get it out all the way.There was blood in the iab tubing.The iab was inserted around 10:00 am on (b)(6) 2014.They noted some blood flakes in the tubing while the patient was in the bath lab.The intra-aortic balloon pump (maquet) was pumping without alarms and under fluoroscope the iab was inflating the patient was taken to the unit.The patient was brought back to the bath lab this evening because of blood in the tubing and an attempt was made to remove the iab.The css explained that they most likely had a small pin hole to the iab during insertion and there was now a clot in the iab.The recommendation was to contact a surgeon to have the iab removed.The patient was going to the operating room for removal.The css tried to get further information about this incident, but the rn did not have time to talk with the css and asked the css to call back tomorrow.The rn did tell the css that this is the first arrow iab that they have inserted.There was no report of patient death.There was a delay or interruption in therapy.It was stated the device was not replaced.The patient outcome is unknown.Additional information received on (b)(6) 2014 per the assistant director of radiology, lead rt for cath lab stated that the (b)(6) male presented with non-stemi to the emergency department.The patient was taken to the cath lab and the cardiology stated the iab was inserted through the sheath via right femoral without issue.The cath lab staff noted blood in the driveline with insertion.The patient twas sent ot the intensive care unit, alert and oriented x3 with no complaints of chest pain.The patient's pressures then went above 100 (augmentation) and the cardiologist decided to remove the iab as there was now more blood in the driveline.There were no alarms reported on the iabp.The patient was taken to the cath lab to remove the iab.The iab was not saved for return.The cardiologist attempted to remove the iab through the sheath and it became entrapped at the very tip of the iab.The patient was then sent to the operating room, iab was removed and the patient was sent back to the unit.The patient was now in cardiogenic shock.The family made dnr (do not resuscitate) and the patient did expire while in the unit.And update received on (b)(4) 2014 per the css stated the sheath used was the one with the side part from the kit.The patient is believed to have expired from cardiogenic shock.It as stated that the purchasing department had just switched to arrow iab's and this was the first one used.An additional update received on (b)(4) 2014 reported that an in-service was scheduled for this hospital.The patient's ef (ejection fraction) was 5%.Per the css, condensation was observed in the tubing and documented several times in the chart from the hospital.When the decision was made to remove the iab the doctor had stated "the patient doesn't need it anymore".Per the assistant director of imaging/cath lab, the patient expired from non-stemi (segment elevation myocardial infarction).

Manufacturer Narrative

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

• 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 road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3835774
• MDR Text Key: 17955816
• Report Number: 1219856-2014-00096
• 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: 04/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2014
• Initial Date FDA Received: 05/14/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR