MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 8 FR - 40 CC FOS

Catalog Number IAB-05840-LWS

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

Patient Problems Cardiomyopathy (1764); Myocardial Infarction (1969); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported that while in the cath lab (cl) he patient had an intra-aortic balloon (iab) inserted via his left femoral artery, using a sheath.The event occurred on the evening of (b)(6) 2014 at approximately 10pm.There were no issues during the insertion.The technician stated that upon arrival for his shift, at approximately 1:30pm on (b)(6) 2014, he was making his rounds in the cicu (cardiac intensive care unit) and noticed dried blood in the tubing.The technician clamped off the tubing and an attempt was made to remove the iab.Resistance was met and the patient was taken down to the operating room.The iab was surgically removed about 3pm.The technician stated that the vascular surgeon had to cut the iab.The bottom half and bifurcation of the iab were not able to be retrieved, but he was able to retrieve the tubing and the top half of the iab.The director of the icu/cticu stated that the cicu staff did not notice anything prior to the balloon rupture that seemed out of the ordinary.There was discussion regarding the lack of a low helium alarm prior to the visual appearance of blood.The intra-aortic balloon pump (serial# (b)(4)) never alarmed.The cath lab and unit nurses confirmed there were no alarms at any time.Follow-up with the md who inserted in the cl said the insertion was smooth and the waveform looked fine.The patient is recovering, but has a good deal of vascular issues related to removal of iab: loss of pulse, embolization to tibial head and below.The patient did not receive another iab because of the vascular complications as a result of the removal.There was a reported delay/interruption in iabp therapy.There were reported patient complications described as surgical cut down removal.There was no reported patient death.Medical/surgical intervention was required.The length of time prior to the event was approximately 15 hours before blood was noticed, but it was dried blood.There were no pump alarms and no pump strips were generated.Additional information received from the sales representative stated that the patient came to the emergency room vt (ventricular tachycardia) / vf (ventricular fibrillation) arrest.After iab removal no loss of pulse was noted to the limb and it was not comprised.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8 FR - 40 CC FOS
• 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; readng, PA 19605 ; 6103780131
• MDR Report Key: 4172040
• MDR Text Key: 5158713
• Report Number: 1219856-2014-00195
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14H0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 25 YR