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

Catalog Number JL40615

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

It was reported that a call was received from the cardiac cath lab (ccl) rn to the hotline on (b)(6) 2015 at 7:52pm est.The clinical support specialist (css) called back and spoke with another rn.The rn stated the patient (pt.) was transferred from another facility earlier today for cath which revealed mvd (mitral valve disease).Approximately three hours ago, an iab-06840-u was inserted through the sheath via femoral artery without issue and the pt was scheduled for a coronary artery bypass graft (cabg) tomorrow.The rn said the pt.Was sent to the intensive care unit (icu) at 5:30pm.A short time ago, the icu staff called the ccl staff due to dampening of the arterial pressure (ap) waveform.When the ccl staff arrived in the icu, they found the central lumen pressure bag was deflated and no ap waveform on the intra-aortic balloon pump (autocat2wave).Hosp policy is to use nss (normal saline solution) for all flush bags.The css verified that the iabp is currently pumping although there is no ap waveform present on the pump.

Manufacturer Narrative

Qn #(b)(4).The central lumen and side port are unable to be flushed or aspirated.The pt.Has no other ap access at this time.The css explained that a radial a-line could be obtained and connected directly to the pump.The rn said they do have a call into the surgeon to see if the surgeon wants the iab to be replaced or obtain an alternate ap source.The css requested if the iab is removed, that it be saved for return.There was no report of pt.Death, complications or injury.No med or surgical intervention was required.There was no delay or interruption in therapy noted.The pt.Outcome is the pt.Remained on iabp therapy as planned.An update received on 02/17/2015 stated that the css spoke with the rn who was involved with this case last evening.The pt.Was taken back to the ccl where they were able to visualize the iab totally inflating and deflating under fluoroscopy.The md attempted to pass the spring wire guide (swg) up through the central lumen, but could not advance the wire.The iab was removed and not replaced.The pt.Was placed back on heparin to await cabg this morning.After removal, the doctor "aggressively" pushed the swg through the central lumen and was able to express a clot from the distal tip of the central lumen.The rn stated that the md may have caused the the iab membrane to tear during this manipulation.A report was filed and iab will go to risk management.The css has dealt with risk management a few times prior and this procedure can be quite lengthy to get the iab back as they need to follow up with the pt post-operatively to insure there were no complications associated with this issue.The css will follow up with risk management at intervals and keep us posted on the status of the return.

• 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 INTERNATIONAL INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4563807
• MDR Text Key: 19609424
• Report Number: 1219856-2015-00040
• 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: 02/16/2015

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: JL40615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 02/26/2015
• 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
• Treatment: HEPARIN